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510(k) K940858

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) by Innovation Sports, Inc. — Product Code ILO

Clearance Details

Decision
SN ()
Decision Date
July 12, 1994
Date Received
February 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type

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