510(k) K873177

DEVINE (SUPRAPUBIC SOUND AND GUIDE) by Penn Medical Devices, Inc. — Product Code KOE

K873177 is an FDA 510(k) premarket notification submitted by Penn Medical Devices, Inc. for the device "DEVINE (SUPRAPUBIC SOUND AND GUIDE)". The FDA issued a decision of Substantially Equivalent on October 14, 1987. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Penn Medical Devices, Inc. has at least 7 other 510(k) clearances on record.