The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Davis And Geck Handheld Inst. Sterilization Tray.
| Device ID | K920293 |
| 510k Number | K920293 |
| Device Name: | DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY |
| Classification | Sterilizer, Steam |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | Kevin J Crossen |
| Correspondent | Kevin J Crossen DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-22 |
| Decision Date | 1992-04-21 |