The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Phaco Tips For Phaco Fragmentation Machines.
| Device ID | K943379 |
| 510k Number | K943379 |
| Device Name: | PHACO TIPS FOR PHACO FRAGMENTATION MACHINES |
| Classification | Unit, Phacofragmentation |
| Applicant | OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
| Contact | James Christensen |
| Correspondent | James Christensen OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-10-11 |