510(k) K130083
K130083 is an FDA 510(k) premarket notification submitted by Demetech Corp. for the device "DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on July 17, 2013. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Demetech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2013
- Date Received
- January 14, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type