FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL LOOPS
K Number: K812389
·
Decision Nov 16, 1981
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
5
Review Days
88
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Basic Information
- Device Name
- SURGICAL LOOPS
- K Number
- K812389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Berkeley Medevices
- Date Received
- August 20, 1981
- Decision Date
- November 16, 1981
- Product Code
- GAD
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
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