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FDA 510(k) Application Details - K193667
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K193667
Device Name
Laser, Comb, Hair
Applicant
Conversion Labs, PR, LLC
53 Calle Las Palmeras, Suite 802
San Juan, PR 00901 US
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Contact
Stefan Galluppi
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
12/31/2019
Decision Date
03/25/2020
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
FDA Source Information for K193667
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