The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Phaco Tips.
| Device ID | K012579 |
| 510k Number | K012579 |
| Device Name: | REPROCESSED PHACO TIPS |
| Classification | Needle, Phacoemulsification, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE N., SUITE 100 Maple Grove, MN 55369 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker STERILMED, INC. 11400 73RD AVE N., SUITE 100 Maple Grove, MN 55369 |
| Product Code | NKX |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-09 |
| Decision Date | 2001-11-08 |
| Summary: | summary |