The following data is part of a premarket notification filed by Mcghan Medical Corp. with the FDA for Mini-motor Hand Engine & Access. Dermabrasion Burs.
| Device ID | K873476 |
| 510k Number | K873476 |
| Device Name: | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | MCGHAN MEDICAL CORP. 700 WARD DR. Santa Barbara, CA 93111 |
| Contact | Gregory M Lee |
| Correspondent | Gregory M Lee MCGHAN MEDICAL CORP. 700 WARD DR. Santa Barbara, CA 93111 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-31 |
| Decision Date | 1987-09-11 |