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FDA 510(k) Application Details - K201854
Device Classification Name
Laser, Comb, Hair
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510(K) Number
K201854
Device Name
Laser, Comb, Hair
Applicant
Nature Incredible Inc
3422 Old Capitol Trail #569
Wilmington, DE 19808 US
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Contact
John Lee
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Regulation Number
890.5500
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Classification Product Code
OAP
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Date Received
07/06/2020
Decision Date
09/01/2020
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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