510(k) K882657

HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT by Harbor Medical Devices, Inc. — Product Code DYB

K882657 is an FDA 510(k) premarket notification submitted by Harbor Medical Devices, Inc. for the device "HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT". The FDA issued a decision of Substantially Equivalent on December 13, 1988. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Harbor Medical Devices, Inc. has at least 6 other 510(k) clearances on record.