The following data is part of a premarket notification filed by Surgiquip, Inc. with the FDA for Snap Drill.
| Device ID | K935516 |
| 510k Number | K935516 |
| Device Name: | SNAP DRILL |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | SURGIQUIP, INC. REGULATORY CONSULTANTS 18665 MIDWAY ROAD, NUMBER 521 Dallas, TX 75287 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers SURGIQUIP, INC. REGULATORY CONSULTANTS 18665 MIDWAY ROAD, NUMBER 521 Dallas, TX 75287 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-01-27 |