FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APPARATUS, SUCTION, WARD USE, PORTAB-
K Number: K843750
·
Decision Oct 11, 1984
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
151
Applicant Total
2
Review Days
16
Basic Information
- Device Name
- APPARATUS, SUCTION, WARD USE, PORTAB-
- K Number
- K843750
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- H.C.H. PRODUCTS, INC.
- Date Received
- September 25, 1984
- Decision Date
- October 11, 1984
- 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 |
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Other Clearances by H.C.H. PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K852646 | THERMATIC SUCTION PUMP | Aug 15, 1985 | Substantially Equivalent |