The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Oms Slimline Phaco Handpiece.
| Device ID | K950218 |
| 510k Number | K950218 |
| Device Name: | OMS SLIMLINE PHACO HANDPIECE |
| Classification | Unit, Phacofragmentation |
| Applicant | OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover, MA 01845 |
| Contact | Gerald A Clay |
| Correspondent | Gerald A Clay OPTICAL MICRO SYSTEMS, INC. 300 WILLOW ST. SOUTH North Andover, MA 01845 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-19 |
| Decision Date | 1995-07-17 |