510(k) K971832

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK by M-Pact Worldwide Management Corp. — Product Code HOZ

K971832 is an FDA 510(k) premarket notification submitted by M-Pact Worldwide Management Corp. for the device "IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK". The FDA issued a decision of Substantially Equivalent on July 31, 1997. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. M-Pact Worldwide Management Corp. has at least 2 other 510(k) clearances on record.