The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Segura Basket.
Device ID | K841942 |
510k Number | K841942 |
Device Name: | SEGURA BASKET |
Classification | Dislodger, Stone, Basket, Ureteral, Metal |
Applicant | VAN-TEC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FFL |
CFR Regulation Number | 876.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-11 |
Decision Date | 1984-07-19 |