The following data is part of a premarket notification filed by San Diego Swiss Machining, Inc. with the FDA for Saphire Plus Surgical Mirror.
| Device ID | K934911 |
| 510k Number | K934911 |
| Device Name: | SAPHIRE PLUS SURGICAL MIRROR |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | SAN DIEGO SWISS MACHINING, INC. 11222 WALABY COURT San Diego, CA 92128 |
| Contact | Alan Donald |
| Correspondent | Alan Donald SAN DIEGO SWISS MACHINING, INC. 11222 WALABY COURT San Diego, CA 92128 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-14 |
| Decision Date | 1994-06-21 |