510(k) K920837

STERILE CONVERTOR SAFECARE GOWN AND DRAPE by Baxter Healthcare Corp — Product Code FYA

K920837 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STERILE CONVERTOR SAFECARE GOWN AND DRAPE". The FDA issued a decision of Substantially Equivalent on May 22, 1992. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Baxter Healthcare Corp has 507 other 510(k) clearances on record.