510(k) K971795

AUTOMATED CHAMBER MAINTENANCE MODULE by Paradigm Medical Industries, Inc. — Product Code HQC

K971795 is an FDA 510(k) premarket notification submitted by Paradigm Medical Industries, Inc. for the device "AUTOMATED CHAMBER MAINTENANCE MODULE". The FDA issued a decision of Substantially Equivalent on July 14, 1997. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Paradigm Medical Industries, Inc. has at least 9 other 510(k) clearances on record.