510(k) K012105

POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM by Symmetry Medical, Inc. — Product Code KCT

K012105 is an FDA 510(k) premarket notification submitted by Symmetry Medical, Inc. for the device "POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 2, 2002. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Symmetry Medical, Inc. has at least 2 other 510(k) clearances on record.