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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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More FDA Info for this Product Code
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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