510(k) K031036

GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 by Gebauer Co. — Product Code MLY

K031036 is an FDA 510(k) premarket notification submitted by Gebauer Co. for the device "GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03". The FDA issued a decision of Substantially Equivalent on July 10, 2003. 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.