510(k) K954791

SEMINAL FLUID COLLECTION KIT II by Apex Medical Technologies, Inc. — Product Code HIS

K954791 is an FDA 510(k) premarket notification submitted by Apex Medical Technologies, Inc. for the device "SEMINAL FLUID COLLECTION KIT II". The FDA issued a decision of Substantially Equivalent on January 5, 1996. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Apex Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.