510(k) K991374

INVIGRA by Indus Medicare , Ltd. — Product Code HIS

K991374 is an FDA 510(k) premarket notification submitted by Indus Medicare , Ltd. for the device "INVIGRA". The FDA issued a decision of Substantially Equivalent on June 15, 1999. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Indus Medicare , Ltd. has at least 7 other 510(k) clearances on record.