The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Van-tec Positive Open Segura Basket.
Device ID | K870615 |
510k Number | K870615 |
Device Name: | VAN-TEC POSITIVE OPEN SEGURA BASKET |
Classification | Dislodger, Stone, Basket, Ureteral, Metal |
Applicant | VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
Contact | James F Vance |
Correspondent | James F Vance VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
Product Code | FFL |
CFR Regulation Number | 876.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-12 |
Decision Date | 1987-03-25 |