The following data is part of a premarket notification filed by Alliance Medical, Inc. with the FDA for Reprocessed Phacoemuisification Tips.
| Device ID | K050518 |
| 510k Number | K050518 |
| Device Name: | REPROCESSED PHACOEMUISIFICATION TIPS |
| Classification | Needle, Phacoemulsification, Reprocessed |
| Applicant | ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. Phoenix, AZ 85044 |
| Contact | Elizabeth Renken |
| Correspondent | Elizabeth Renken ALLIANCE MEDICAL, INC. 10232 SOUTH 51 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 | 2005-03-01 |
| Decision Date | 2005-09-23 |
| Summary: | summary |