The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Davis+geck Visaduct Kit.
| Device ID | K894685 |
| 510k Number | K894685 |
| Device Name: | DAVIS+GECK VISADUCT KIT |
| Classification | General Surgery Tray |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | R. I Pelletier |
| Correspondent | R. I Pelletier DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-25 |
| Decision Date | 1989-08-22 |