510(k) K970916

H.V. PULSE LAVAGE (L31 SERIES) by Global Medical Products, Inc. — Product Code FQH

K970916 is an FDA 510(k) premarket notification submitted by Global Medical Products, Inc. for the device "H.V. PULSE LAVAGE (L31 SERIES)". The FDA issued a decision of Substantially Equivalent on June 20, 1997. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Global Medical Products, Inc. has at least 5 other 510(k) clearances on record.