The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Site 19 Gauge Ultrasonic I/a Phaco Needle.
| Device ID | K904151 |
| 510k Number | K904151 |
| Device Name: | SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE |
| Classification | Unit, Phacofragmentation |
| Applicant | SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | James K Mccracken |
| Correspondent | James K Mccracken SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-07 |
| Decision Date | 1990-12-05 |