510(k) K950850

GENT-L-KARE LACERATION TRAYS by Premium Plastics, Inc. — Product Code FRG

K950850 is an FDA 510(k) premarket notification submitted by Premium Plastics, Inc. for the device "GENT-L-KARE LACERATION TRAYS". The FDA issued a decision of SN on March 14, 1995. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Premium Plastics, Inc. has at least 8 other 510(k) clearances on record.