The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Davis & Geck Valtrac(r) Biofrag Anastomosis Ring.
| Device ID | K913411 |
| 510k Number | K913411 |
| Device Name: | DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING |
| Classification | Staple, Implantable |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | Tamsett |
| Correspondent | Tamsett DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-31 |
| Decision Date | 1991-09-06 |