510(k) K930588
K930588 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1994
- Date Received
- February 4, 1993
- 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