The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Nylon Coated Specula.
| Device ID | K925501 |
| 510k Number | K925501 |
| Device Name: | NYLON COATED SPECULA |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Trish Willging |
| Correspondent | Trish Willging ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-30 |
| Decision Date | 1997-06-13 |