The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corporation with the FDA for Cranial Drill Bits And Accessories.
| Device ID | K170442 |
| 510k Number | K170442 |
| Device Name: | Cranial Drill Bits And Accessories |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | Ad-Tech Medical Instrument Corporation 1901 William Street Racine, WI 53404 |
| Contact | Lisa Theama |
| Correspondent | Gary J. Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-14 |
| Decision Date | 2017-09-07 |
| Summary: | summary |