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 |