510(k) K963596

POLAR CARE 300 by Breg, Inc. — Product Code ILO

K963596 is an FDA 510(k) premarket notification submitted by Breg, Inc. for the device "POLAR CARE 300". The FDA issued a decision of Substantially Equivalent on December 4, 1996. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Breg, Inc. has at least 10 other 510(k) clearances on record.