510(k) K852443

PHARMA-PLAST CLINIPAK by Pharma-Plast USA, Inc. — Product Code FMF

K852443 is an FDA 510(k) premarket notification submitted by Pharma-Plast USA, Inc. for the device "PHARMA-PLAST CLINIPAK". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Pharma-Plast USA, Inc. has at least 8 other 510(k) clearances on record.