The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Athroscopics Burs.
| Device ID | K012605 |
| 510k Number | K012605 |
| Device Name: | REPROCESSED ATHROSCOPICS 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 | 2001-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825014729 | K012605 | 000 |
| 30885825014408 | K012605 | 000 |
| 30885825014415 | K012605 | 000 |
| 30885825014446 | K012605 | 000 |
| 30885825014460 | K012605 | 000 |
| 30885825014484 | K012605 | 000 |
| 30885825014552 | K012605 | 000 |
| 30885825014576 | K012605 | 000 |
| 30885825014583 | K012605 | 000 |
| 30885825014644 | K012605 | 000 |
| 30885825014675 | K012605 | 000 |
| 30885825014682 | K012605 | 000 |
| 30885825014705 | K012605 | 000 |
| 30885825014712 | K012605 | 000 |
| 30885825014231 | K012605 | 000 |