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-gu Use.
| Device ID | K926016 |
| 510k Number | K926016 |
| Device Name: | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-30 |
| Decision Date | 1993-11-12 |