SOFSILK SUTURE
FDA 510(k) clearance K981128 · decided 1998-05-11
Clearance details
- K-number
- K981128
- Device name
- SOFSILK SUTURE
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1998-03-30
- Decision date
- 1998-05-11
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- GAP
- Device class
- 2
- Regulation number
- 878.5030
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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