510(k) K792221

VANCE PHILIPS FOLLOWER CATHETER & BOUGIE by Vance Products, Inc. — Product Code KOE

K792221 is an FDA 510(k) premarket notification submitted by Vance Products, Inc. for the device "VANCE PHILIPS FOLLOWER CATHETER & BOUGIE". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Vance Products, Inc. has at least 10 other 510(k) clearances on record.