510(k) K933726

MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM by Augustine Medical, Inc. — Product Code LHC

K933726 is an FDA 510(k) premarket notification submitted by Augustine Medical, Inc. for the device "MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Augustine Medical, Inc. has at least 10 other 510(k) clearances on record.