510(k) K873178

URETERAL BULB DILATORS by Penn Medical Devices, Inc. — Product Code EZN

K873178 is an FDA 510(k) premarket notification submitted by Penn Medical Devices, Inc. for the device "URETERAL BULB DILATORS". The FDA issued a decision of Substantially Equivalent on September 30, 1987. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Penn Medical Devices, Inc. has at least 7 other 510(k) clearances on record.