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FDA 510(k) Application Details - K161602
Device Classification Name
System, Thermal Regulating
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510(K) Number
K161602
Device Name
System, Thermal Regulating
Applicant
Medivance, Inc.
321 South Taylor Ave, Suite 200
Louisville, CO 80027 US
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Contact
Stacci Cronk
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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
06/09/2016
Decision Date
09/02/2016
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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