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510(k) K073675

T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP by Gaymar Industries, Inc. — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2008
Date Received
December 28, 2007
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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