The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Surgical Loupes.
| Device ID | K891895 |
| 510k Number | K891895 |
| Device Name: | SURGICAL LOUPES |
| Classification | Loupe, Diagnostic/surgical |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Anna Straight |
| Correspondent | Anna Straight ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | FSP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-04-12 |