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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pack, hot or cold, water circulating
510(k) Number K936143
Device Name ISOCOMFORTER
Applicant
ISOCOMFORTER, INC.
4445-b breton rd., s.e.,
suite 310
kentwood,  MI  49508
Applicant Contact imad mahawili
Correspondent
ISOCOMFORTER, INC.
4445-b breton rd., s.e.,
suite 310
kentwood,  MI  49508
Correspodent Contact imad mahawili
Regulation Number890.5720
Classification Product Code
ILO  
Date Received12/27/1993
Decision Date 07/12/1994
Decision (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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