The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Site 810e Photocoagulator And Accessories.
| Device ID | K895663 |
| 510k Number | K895663 |
| Device Name: | SITE 810E PHOTOCOAGULATOR AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-12-04 |