510(k) K902324

TP AND DESIGN, CONDOM by China National Medicines & Health Prod. I/E Corp. — Product Code HIS

K902324 is an FDA 510(k) premarket notification submitted by China National Medicines & Health Prod. I/E Corp. for the device "TP AND DESIGN, CONDOM". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. China National Medicines & Health Prod. I/E Corp. has at least 10 other 510(k) clearances on record.