The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Site Sterilization Trays For Ophthalmic Use.
| Device ID | K883098 |
| 510k Number | K883098 |
| Device Name: | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE |
| Classification | Tray, Surgical |
| Applicant | SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | Mccracken |
| Correspondent | Mccracken SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Product Code | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-22 |
| Decision Date | 1988-08-18 |