510(k) K113686

KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED by Mayer Laboratories, Inc. — Product Code HIS

K113686 is an FDA 510(k) premarket notification submitted by Mayer Laboratories, Inc. for the device "KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED". The FDA issued a decision of Substantially Equivalent on March 6, 2012. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Mayer Laboratories, Inc. has at least 10 other 510(k) clearances on record.