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FDA 510(k) Application Details - K162071
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K162071
Device Name
Laser, Comb, Hair
Applicant
EGLOBAL, LLC
10115 E BELL RD STE 107
SCOTTSDALE, AZ 85260 US
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Contact
WAYNE DESTEFANO
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
07/27/2016
Decision Date
02/24/2017
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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