510(k) K946170

COMFORT-Q SUBCUTANEOUS INJECTION SETS by B. Braun of America, Inc. — Product Code FOZ

K946170 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "COMFORT-Q SUBCUTANEOUS INJECTION SETS". The FDA issued a decision of Substantially Equivalent on November 3, 1995. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.