FDA 510(k) Application Details - K210603

Device Classification Name System, Thermal Regulating

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510(K) Number K210603
Device Name System, Thermal Regulating
Applicant 3M Company
3M Center, 2510 Conway Ave.
Bldg. 275-5W-06
St. Paul, MN 55144 US
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Contact Brian Kleiber
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Regulation Number 870.5900

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Classification Product Code DWJ
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Date Received 03/01/2021
Decision Date 03/30/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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