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FDA 510(k) Application Details - K162022
Device Classification Name
Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
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510(K) Number
K162022
Device Name
Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant
Tanses Technologies inc.
4450 Highway 13
Fabreville H7R 6E9 CA
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Contact
Kirk Kiremitci
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Regulation Number
890.5500
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Classification Product Code
NHN
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Date Received
07/21/2016
Decision Date
12/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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