510(k) K931612
K931612 is an FDA 510(k) premarket notification submitted by S. Jackson, Inc. for the device "NYLAMID SUTURE". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. S. Jackson, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1993
- Date Received
- April 1, 1993
- 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