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 Polyglycolic Acid Suture.
| Device ID | K951352 |
| 510k Number | K951352 |
| Device Name: | DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
| Contact | S. J Tamsett |
| Correspondent | S. J Tamsett DAVIS & GECK, INC. ONE CASPER ST. 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 | 1995-03-24 |
| Decision Date | 1995-06-05 |