FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NO-GAUZE LAPAROTOMY SPONGE
K Number: K823671
·
Decision Jan 9, 1983
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
5
Review Days
33
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Basic Information
- Device Name
- NO-GAUZE LAPAROTOMY SPONGE
- K Number
- K823671
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgilite Intl., Inc.
- Date Received
- December 7, 1982
- Decision Date
- January 9, 1983
- Product Code
- GDY
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
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