The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Van-tec Pumping System.
Device ID | K870557 |
510k Number | K870557 |
Device Name: | VAN-TEC PUMPING SYSTEM |
Classification | Catheter, Urological |
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 | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-10 |
Decision Date | 1987-03-30 |