FDA 510(k) Application Details - K171373

Device Classification Name System, Thermal Regulating

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510(K) Number K171373
Device Name System, Thermal Regulating
Applicant 3M Company
3M Center, Building 275-5W-06
St. Paul, MN 55144 US
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Contact Jon Platt
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Regulation Number 870.5900

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Classification Product Code DWJ
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Date Received 05/10/2017
Decision Date 10/10/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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