510(k) K032671

GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 by Gebauer Co. — Product Code MLY

K032671 is an FDA 510(k) premarket notification submitted by Gebauer Co. for the device "GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07". The FDA issued a decision of Substantially Equivalent on March 17, 2004. The device falls under product code MLY (Vapocoolant Device), a Class U device. Gebauer Co. has at least 10 other 510(k) clearances on record.