510(k) K885019

BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. by Bemis Health Care — Product Code FRG

K885019 is an FDA 510(k) premarket notification submitted by Bemis Health Care for the device "BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.". The FDA issued a decision of Substantially Equivalent on January 25, 1989. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Bemis Health Care has at least 10 other 510(k) clearances on record.