The following data is part of a premarket notification filed by Synvasive Technology, Inc. with the FDA for Surgical Burs And Surgical Drill Bits.
| Device ID | K972508 |
| 510k Number | K972508 |
| Device Name: | SURGICAL BURS AND SURGICAL DRILL BITS |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | SYNVASIVE TECHNOLOGY, INC. 4925 ROBERT J MATHEWS PKWY. El Dorado, CA 95762 |
| Contact | Michael G Fisher |
| Correspondent | Michael G Fisher SYNVASIVE TECHNOLOGY, INC. 4925 ROBERT J MATHEWS PKWY. El Dorado, CA 95762 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-08-26 |
| Summary: | summary |