510(k) K233777

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) by Primed Medical Products, Inc. — Product Code FRG

K233777 is an FDA 510(k) premarket notification submitted by Primed Medical Products, Inc. for the device "PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)". The FDA issued a decision of Substantially Equivalent on May 24, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Primed Medical Products, Inc. has at least 7 other 510(k) clearances on record.