The following data is part of a premarket notification filed by Spire Medical, Inc. with the FDA for Micro-surgical Power Instrument System.
| Device ID | K802463 |
| 510k Number | K802463 |
| Device Name: | MICRO-SURGICAL POWER INSTRUMENT SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | SPIRE MEDICAL, INC. 1884 EASTMAN AVE., #105 Ventura, CA 93003 |
| Contact | David C Esslinger |
| Correspondent | David C Esslinger SPIRE MEDICAL, INC. 1884 EASTMAN AVE., #105 Ventura, CA 93003 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-09 |
| Decision Date | 1980-10-31 |