510(k) K831085

SYNEVAC VACUUM SOURCE UNIT by Synemed, Inc. — Product Code BTA

K831085 is an FDA 510(k) premarket notification submitted by Synemed, Inc. for the device "SYNEVAC VACUUM SOURCE UNIT". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Synemed, Inc. has at least 7 other 510(k) clearances on record.