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FDA 510(k) Application Details - K240456
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K240456
Device Name
Laser, Comb, Hair
Applicant
PLM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
1499 NW 79th Ave
Miami, FL 33126 US
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Contact
Ira Nusbaum
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
02/15/2024
Decision Date
05/22/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K240456
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