The following data is part of a premarket notification filed by American Cyanamid Co. with the FDA for Davis+geck Valtrac Biofrag Anastomosis Ring.
| Device ID | K931056 |
| 510k Number | K931056 |
| Device Name: | DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING |
| Classification | Staple, Implantable |
| Applicant | AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Contact | Tamsett |
| Correspondent | Tamsett AMERICAN CYANAMID CO. ONE CASPER ST. 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 | 1993-03-01 |
| Decision Date | 1993-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521052505 | K931056 | 000 |
| 10884521052499 | K931056 | 000 |
| 10884521052444 | K931056 | 000 |
| 10884521052451 | K931056 | 000 |
| 10884521052482 | K931056 | 000 |
| 10884521052475 | K931056 | 000 |
| 10884521052437 | K931056 | 000 |
| 10884521052420 | K931056 | 000 |
| 10884521052468 | K931056 | 000 |