The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Zanlex, Zan-tex & Zandex.
| Device ID | K830511 |
| 510k Number | K830511 |
| Device Name: | ZANLEX, ZAN-TEX & ZANDEX |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | WINN HIRSCH & ASSOC. 30 SYLVIA ROAD Plainview , NY 11803 - |
| Contact | Win Hirsch |
| Correspondent | Win Hirsch WINN HIRSCH & ASSOC. 30 SYLVIA ROAD Plainview , NY 11803 - |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-17 |
| Decision Date | 1983-03-17 |