FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A-SORB
K Number: K882115
·
Decision Oct 3, 1988
Classifications
1
FEI Numbers
585
Registration Numbers
585
Same Product Code
67
Applicant Total
3
Review Days
137
Basic Information
- Device Name
- A-SORB
- K Number
- K882115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- HOWARD MEDICAL CO.
- Date Received
- May 19, 1988
- Decision Date
- October 3, 1988
- Product Code
- NAB
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | FDA class 1 | General, Plastic Surgery |
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