510(k) K093307

ASEPT PLEURAL DRAINAGE SYSTEM by Pfm Medical, Inc. — Product Code DWM

K093307 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "ASEPT PLEURAL DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 6, 2009. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.