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510(k) K964354

ARTOCOOL-S WATER CIRCULATING COLD PACK by Ormed GmbH — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1997
Date Received
October 31, 1996
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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