The following data is part of a premarket notification filed by Alliance Medical Corp. with the FDA for Reprocessed Phacoemulsification Tips.
| Device ID | K060648 |
| 510k Number | K060648 |
| Device Name: | REPROCESSED PHACOEMULSIFICATION TIPS |
| Classification | Needle, Phacoemulsification, Reprocessed |
| Applicant | ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Moiira Barton |
| Correspondent | Moiira Barton ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NKX |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-13 |
| Decision Date | 2007-03-19 |
| Summary: | summary |