510(k) K926137

ANAGO FEM-COOL/FEM-COOL PETITE by Anago, Inc. — Product Code IMD

K926137 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "ANAGO FEM-COOL/FEM-COOL PETITE". The FDA issued a decision of Substantially Equivalent on May 26, 1993. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Anago, Inc. has at least 10 other 510(k) clearances on record.