The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Surgilene(r) Sutures.
| Device ID | K945701 |
| 510k Number | K945701 |
| Device Name: | SURGILENE(R) SUTURES |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | Steve Tamsett |
| Correspondent | Steve Tamsett DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-01-24 |