FDA 510(k) Application Details - K952329

Device Classification Name System, Thermal Regulating

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510(K) Number K952329
Device Name System, Thermal Regulating
Applicant PROGRESSIVE DYNAMICS, INC.
507 INDUSTRIAL RD.
MARSHALL, MI 49068-1796 US
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Contact WILLIAM F LOHNESS
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Regulation Number 870.5900

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Classification Product Code DWJ
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Date Received 05/18/1995
Decision Date 01/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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