The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Appose Unity Sterile Disposable Skin Stapler.
| Device ID | K900486 |
| 510k Number | K900486 |
| Device Name: | APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER |
| Classification | Staple, Removable (skin) |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | B. I Parzuchowski |
| Correspondent | B. I Parzuchowski DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | GDT |
| CFR Regulation Number | 878.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-01 |
| Decision Date | 1990-04-20 |