FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOVAC CLOSED WOUND SUCTION SYSTEM
K Number: K930615
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
38
Review Days
382
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Basic Information
- Device Name
- AUTOVAC CLOSED WOUND SUCTION SYSTEM
- K Number
- K930615
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boehringer Laboratories
- Date Received
- February 5, 1993
- Decision Date
- February 22, 1994
- 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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