The following data is part of a premarket notification filed by Brassler Usa with the FDA for Komet Medical Surgical Power Accesories.
| Device ID | K930109 |
| 510k Number | K930109 |
| Device Name: | KOMET MEDICAL SURGICAL POWER ACCESORIES |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | BRASSLER USA 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook BRASSLER USA 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-11 |
| Decision Date | 1993-08-25 |