The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Dexon S, Dexon Plus, And Dexon Ii Polycolic Acid.
| Device ID | K930588 |
| 510k Number | K930588 |
| Device Name: | DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | John Schaefer |
| Correspondent | John Schaefer DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-04 |
| Decision Date | 1994-01-07 |