The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vance Philips Follower Catheter & Bougie.
| Device ID | K792221 |
| 510k Number | K792221 |
| Device Name: | VANCE PHILIPS FOLLOWER CATHETER & BOUGIE |
| Classification | Dilator, Urethral |
| Applicant | VANCE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-05 |
| Decision Date | 1979-12-06 |