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FDA 510(k) Application Details - K193008
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K193008
Device Name
Laser, Comb, Hair
Applicant
Advihair S.R.L.
Via Benini 11
Zola Predosa 40069 IT
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Contact
Angleo DÆAndrea
Other 510(k) Applications for this Contact
Regulation Number
890.5500
More FDA Info for this Regulation Number
Classification Product Code
OAP
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More FDA Info for this Product Code
Date Received
10/28/2019
Decision Date
12/03/2020
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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