510(k) K031463

MARINA MEDICAL SILICONE PESSARY by Marina Medical Instruments, Inc. — Product Code HHW

K031463 is an FDA 510(k) premarket notification submitted by Marina Medical Instruments, Inc. for the device "MARINA MEDICAL SILICONE PESSARY". The FDA issued a decision of Substantially Equivalent on November 18, 2003. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Marina Medical Instruments, Inc. has at least 4 other 510(k) clearances on record.