510(k) K883582

VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM by Surgidyne, Inc. — Product Code BTA

K883582 is an FDA 510(k) premarket notification submitted by Surgidyne, Inc. for the device "VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 3, 1988. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Surgidyne, Inc. has at least 5 other 510(k) clearances on record.