The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Pollack Chain Cysourethrogram Set.
Device ID | K810370 |
510k Number | K810370 |
Device Name: | POLLACK CHAIN CYSOURETHROGRAM SET |
Classification | Catheter, Urethrographic, Male |
Applicant | VANCE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FGI |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-12 |
Decision Date | 1981-03-20 |