510(k) K802139

SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY by Dyn-A-Med Products — Product Code HHT

K802139 is an FDA 510(k) premarket notification submitted by Dyn-A-Med Products for the device "SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Dyn-A-Med Products has at least 4 other 510(k) clearances on record.