The following data is part of a premarket notification filed by American Medical Specialties, Inc. with the FDA for Burrs.
| Device ID | K934583 |
| 510k Number | K934583 |
| Device Name: | BURRS |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | AMERICAN MEDICAL SPECIALTIES, INC. 1080 HOLCOMB BRIDGE ROAD. BLDG. 100 STE. 300 Roswell, GA 30076 |
| Contact | Roger Eaglen |
| Correspondent | Roger Eaglen AMERICAN MEDICAL SPECIALTIES, INC. 1080 HOLCOMB BRIDGE ROAD. BLDG. 100 STE. 300 Roswell, GA 30076 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-23 |
| Decision Date | 1994-01-26 |