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FDA 510(k) Application Details - K122950
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K122950
Device Name
Laser, Comb, Hair
Applicant
THERADOME INC.
4900 HOPYARD ROAD
SUITE 100
PLEASANTON, CA 94588 US
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Contact
LARRY PETERSEN
Other 510(k) Applications for this Contact
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
09/25/2012
Decision Date
06/14/2013
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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