DEMETECH SILK NONABSORBABLE SUTURE
FDA 510(k) clearance K023029 · decided 2002-11-25
Clearance details
- K-number
- K023029
- Device name
- DEMETECH SILK NONABSORBABLE SUTURE
- Applicant
- Demetech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-11
- Decision date
- 2002-11-25
- Days to decision
- 75 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
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.