The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Dyonics Arthroscopic Burs.
| Device ID | K012652 |
| 510k Number | K012652 |
| Device Name: | REPROCESSED DYONICS ARTHROSCOPIC BURS |
| Classification | Arthroscope |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Don Selvey |
| Correspondent | Don Selvey ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST 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 | 2001-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825014668 | K012652 | 000 |
| 30885825012954 | K012652 | 000 |
| 30885825012961 | K012652 | 000 |
| 30885825012978 | K012652 | 000 |
| 30885825012985 | K012652 | 000 |
| 30885825012992 | K012652 | 000 |
| 30885825013005 | K012652 | 000 |
| 30885825013012 | K012652 | 000 |
| 30885825013036 | K012652 | 000 |
| 30885825013043 | K012652 | 000 |
| 30885825013050 | K012652 | 000 |
| 30885825013616 | K012652 | 000 |
| 30885825013685 | K012652 | 000 |
| 30885825014200 | K012652 | 000 |
| 30885825012947 | K012652 | 000 |