The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Stryker Arthroscopic Shavers.
| Device ID | K012635 |
| 510k Number | K012635 |
| Device Name: | REPROCESSED STRYKER ARTHROSCOPIC SHAVERS |
| 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 |
|---|---|---|
| 30885825014743 | K012635 | 000 |
| 30885825014248 | K012635 | 000 |
| 30885825014286 | K012635 | 000 |
| 30885825014361 | K012635 | 000 |
| 30885825014378 | K012635 | 000 |
| 30885825014385 | K012635 | 000 |
| 30885825014392 | K012635 | 000 |
| 30885825014477 | K012635 | 000 |
| 30885825014545 | K012635 | 000 |
| 30885825014569 | K012635 | 000 |
| 30885825014699 | K012635 | 000 |
| 30885825014736 | K012635 | 000 |
| 30885825014224 | K012635 | 000 |