The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Davis & Geck Chromic & Plain Gut Ligature Carrier.
| Device ID | K912319 |
| 510k Number | K912319 |
| Device Name: | DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | Blanche Parzuchowski |
| Correspondent | Blanche Parzuchowski DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1991-08-22 |