The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Needle Holders & Access For Lapar Surg-ob/gyn Use.
| Device ID | K926021 |
| 510k Number | K926021 |
| Device Name: | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-30 |
| Decision Date | 1994-04-07 |