The following data is part of a premarket notification filed by Delta Surgical Instruments, Inc. with the FDA for Dsi Pins And Wires.
| Device ID | K060654 |
| 510k Number | K060654 |
| Device Name: | DSI PINS AND WIRES |
| Classification | Pin, Fixation, Smooth |
| Applicant | DELTA SURGICAL INSTRUMENTS, INC. 95 SCHUNNEMUNK RD. Highland Mills, NY 10930 |
| Contact | Dandenia Zabat |
| Correspondent | Dandenia Zabat DELTA SURGICAL INSTRUMENTS, INC. 95 SCHUNNEMUNK RD. Highland Mills, NY 10930 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-13 |
| Decision Date | 2006-04-28 |
| Summary: | summary |