The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Diamond Burs.
| Device ID | K041978 |
| 510k Number | K041978 |
| Device Name: | REPROCESSED DIAMOND BURS |
| Classification | Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Eric Varty |
| Correspondent | Eric Varty ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLN |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-23 |
| Decision Date | 2004-11-23 |
| Summary: | summary |