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FDA 510(k) Application Details - K181878
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K181878
Device Name
Laser, Comb, Hair
Applicant
Kiierr International, LLC
863 East Downington Avenue
Salt Lake City, UT 84105-3211 US
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Contact
Michael Anderson
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Regulation Number
890.5500
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Classification Product Code
OAP
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More FDA Info for this Product Code
Date Received
07/13/2018
Decision Date
09/05/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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