MANI NEEDLE & SUTURE PACK (SILK)
FDA 510(k) clearance K053638 · decided 2006-05-19
Clearance details
- K-number
- K053638
- Device name
- MANI NEEDLE & SUTURE PACK (SILK)
- Applicant
- Mani, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-29
- Decision date
- 2006-05-19
- Days to decision
- 141 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
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.