The following data is part of a premarket notification filed by Adven Medical with the FDA for Reprocessed Used, Disposable Blades, Burs, Bits And Taps.
| Device ID | K012676 |
| 510k Number | K012676 |
| Device Name: | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | ADVEN MEDICAL 1001 SLATON HWY. Lubbock, TX 79404 |
| Contact | Mark W Aldana |
| Correspondent | Mark W Aldana ADVEN MEDICAL 1001 SLATON HWY. Lubbock, TX 79404 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2002-02-04 |
| Summary: | summary |