The following data is part of a premarket notification filed by Site Microsurgical Systems, Inc. with the FDA for Modified Site Fiber Optic Module For Ophthal. Use.
| Device ID | K883480 |
| 510k Number | K883480 |
| Device Name: | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE |
| Classification | Headlight, Fiberoptic Focusing |
| 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 | FCT |
| CFR Regulation Number | 886.4335 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-08-24 |