510(k) K970857

ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO by Davis & Geck, Inc. — Product Code CAC

K970857 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO". The FDA issued a decision of Substantially Equivalent on November 5, 1997. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.