FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROVAC WOUND DRAINAGE & HEALING SYS
K Number: K840913
·
Decision Apr 24, 1984
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
1
Review Days
55
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Basic Information
- Device Name
- PROVAC WOUND DRAINAGE & HEALING SYS
- K Number
- K840913
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Meyer Medical U.S.A., Inc.
- Date Received
- February 29, 1984
- Decision Date
- April 24, 1984
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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