510(k) K172203

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray by Nuance Medical, LLC — Product Code MLY

K172203 is an FDA 510(k) premarket notification submitted by Nuance Medical, LLC for the device "CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray". The FDA issued a decision of Substantially Equivalent on October 18, 2017. The device falls under product code MLY (Vapocoolant Device), a Class U device. Nuance Medical, LLC has at least 5 other 510(k) clearances on record.