The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Dexon Dissecting Sponge.
| Device ID | K914365 |
| 510k Number | K914365 |
| Device Name: | DEXON DISSECTING SPONGE |
| Classification | Suture, Absorbable |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | Stephan Tamsett |
| Correspondent | Stephan Tamsett DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | GAK |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1991-10-23 |