The following data is part of a premarket notification filed by U.s. Iol, Inc. with the FDA for U.s. Iol Phaco Handpiece.
| Device ID | K954239 |
| 510k Number | K954239 |
| Device Name: | U.S. IOL PHACO HANDPIECE |
| Classification | Unit, Phacofragmentation |
| Applicant | U.S. IOL, INC. 9327 BLACKLEY ST. Temple City, CA 91789 |
| Contact | Glenn Dunki-jacobs |
| Correspondent | Glenn Dunki-jacobs U.S. IOL, INC. 9327 BLACKLEY ST. Temple City, CA 91789 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-11 |
| Decision Date | 1995-12-08 |