The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Site Phacoemulsification Syst/ophthalmic Use (mod).
| Device ID | K864301 |
| 510k Number | K864301 |
| Device Name: | SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD) |
| 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 | 1986-10-31 |
| Decision Date | 1986-12-15 |