510(k) K840344

PDI PREPMASTER WET PACK MINOR PROCEDURE by Nice-Pak Products, Inc. — Product Code FRG

K840344 is an FDA 510(k) premarket notification submitted by Nice-Pak Products, Inc. for the device "PDI PREPMASTER WET PACK MINOR PROCEDURE". The FDA issued a decision of Substantially Equivalent on March 26, 1984. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Nice-Pak Products, Inc. has at least 8 other 510(k) clearances on record.