510(k) K902508

LAKE MALE EXTERNAL CATHETERIZATION KIT by Lake Medical Products, Inc. — Product Code FCM

K902508 is an FDA 510(k) premarket notification submitted by Lake Medical Products, Inc. for the device "LAKE MALE EXTERNAL CATHETERIZATION KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on August 23, 1990. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. Lake Medical Products, Inc. has at least 10 other 510(k) clearances on record.