FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
K Number: K971107
·
Decision Jun 5, 1997
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
39
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
- K Number
- K971107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alexander Mfg. Co.
- Date Received
- March 26, 1997
- Decision Date
- June 5, 1997
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTA), ordered by most recent decision date.
Momcozy Nasal Aspirator (BN007)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Suction Pump (SU-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Alexander Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K982896 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 | Oct 21, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K981776 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X | Aug 3, 1998 | Substantially Equivalent |
| K981728 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 | Jun 26, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K980224 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 | Apr 2, 1998 | Substantially Equivalent |
| K974061 | RECHARGEABLE BATTERY PART NUMBER GL825-200 | Jan 16, 1998 | Substantially Equivalent |
| K973851 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 | Jan 5, 1998 | Substantially Equivalent |
| K973850 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 | Nov 12, 1997 | Substantially Equivalent |
| K972746 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 | Oct 21, 1997 | Substantially Equivalent |
| K972780 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 | Oct 20, 1997 | Substantially Equivalent |
| K972779 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P | Oct 20, 1997 | Substantially Equivalent |