The following data is part of a premarket notification filed by Alliance Medical, Inc. with the FDA for Reprocessed Linvatec Arthroscopic Burs.
| Device ID | K012630 |
| 510k Number | K012630 |
| Device Name: | REPROCESSED LINVATEC ARTHROSCOPIC BURS |
| Classification | Arthroscope |
| Applicant | ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. Phoenix, AZ 85044 |
| Contact | Don Selvey |
| Correspondent | Don Selvey ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. Phoenix, AZ 85044 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-11-09 |
| Summary: | summary |