510(k) K053638
K053638 is an FDA 510(k) premarket notification submitted by Mani, Inc. for the device "MANI NEEDLE & SUTURE PACK (SILK)". The FDA issued a decision of Substantially Equivalent on May 19, 2006. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Mani, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2006
- Date Received
- December 29, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Silk
- Device Class
- Class II
- Regulation Number
- 878.5030
- Review Panel
- SU
- Submission Type