510(k) K964855

EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD by Shippert Medical Technologies Corp. — Product Code HOZ

K964855 is an FDA 510(k) premarket notification submitted by Shippert Medical Technologies Corp. for the device "EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD". The FDA issued a decision of Substantially Equivalent on March 4, 1997. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Shippert Medical Technologies Corp. has at least 10 other 510(k) clearances on record.