The following data is part of a premarket notification filed by Spire Medical, Inc. with the FDA for Dermabraders.
| Device ID | K821485 |
| 510k Number | K821485 |
| Device Name: | DERMABRADERS |
| Classification | Bur, Surgical, General & Plastic Surgery |
| 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 | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-18 |
| Decision Date | 1982-06-10 |