510(k) K990567

GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH by Global Healthcare, Inc. — Product Code FRG

K990567 is an FDA 510(k) premarket notification submitted by Global Healthcare, Inc. for the device "GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH". The FDA issued a decision of Substantially Equivalent on April 5, 1999. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Global Healthcare, Inc. has at least 2 other 510(k) clearances on record.