The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Valtrac Pursesting Device.
| Device ID | K851452 |
| 510k Number | K851452 |
| Device Name: | VALTRAC PURSESTING DEVICE |
| Classification | Instrument, Ligature Passing And Knot Tying |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | Pelletier |
| Correspondent | Pelletier DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | HCF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-11 |
| Decision Date | 1985-06-12 |