The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Ureteral Catheter Connector.
Device ID | K820868 |
510k Number | K820868 |
Device Name: | URETERAL CATHETER CONNECTOR |
Classification | Catheter, Urological |
Applicant | VAN-TEC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-29 |
Decision Date | 1982-04-26 |