The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Appose Ultra Dispos. Skin Stapler W/auto Release.
| Device ID | K844417 |
| 510k Number | K844417 |
| Device Name: | APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE |
| Classification | Stapler, Surgical |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | Pelletier |
| Correspondent | Pelletier DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-15 |
| Decision Date | 1984-12-17 |