FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
K Number: K963558
·
Decision Dec 4, 1996
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
75
Applicant Total
5
Review Days
90
Basic Information
- Device Name
- CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
- K Number
- K963558
- 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
- CONTEMPORARY PRODUCTS, INC.
- Date Received
- September 5, 1996
- Decision Date
- December 4, 1996
- Product Code
- JCX
- 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 |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | FDA class 2 | General, Plastic Surgery |
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