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510(k) K083008

COOLSKIN by Elbio Co., Ltd. — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2009
Date Received
October 8, 2008
Clearance Type
Abbreviated
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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