510(k) K081366
K081366 is an FDA 510(k) premarket notification submitted by Nashville Surgical Instruments for the device "KUMAR T-ANCHORS HERNIA SET". The FDA issued a decision of Substantially Equivalent on July 15, 2008. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Nashville Surgical Instruments has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2008
- Date Received
- May 15, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Device Class
- Class II
- Regulation Number
- 878.5020
- Review Panel
- SU
- Submission Type