FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISP. SYRINGES: 2,5 & L0 MI.
K Number: K771272
·
Decision Sep 12, 1977
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
7
Review Days
84
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Basic Information
- Device Name
- DISP. SYRINGES: 2,5 & L0 MI.
- K Number
- K771272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Berman, Pcp & Consultants, Inc.
- Date Received
- June 20, 1977
- Decision Date
- September 12, 1977
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by Berman, Pcp & Consultants, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K771983 | SCALP VEIN SET | Jan 5, 1978 | Substantially Equivalent |
| K771269 | BLOOD COLLECTION SET TYPE H | Sep 12, 1977 | Substantially Equivalent |
| K771270 | BLOOD ADMINISTRATION TYPE R | Sep 12, 1977 | Substantially Equivalent |
| K771267 | INFUSION SET TYPE S | Sep 12, 1977 | Substantially Equivalent |
| K771271 | SCALP VEIN SET | Sep 12, 1977 | Substantially Equivalent |
| K771268 | INFUSION SET TYPE J | Sep 12, 1977 | Substantially Equivalent |