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FDA 510(k) Application Details - K160880
Device Classification Name
More FDA Info for this Device
510(K) Number
K160880
Device Name
Photonica Professional
Applicant
Ward Photonics LLC
1980 N Atlantic Avenue
Cocoa Beach, FL 32931 US
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Contact
Terry Ward
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Regulation Number
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Classification Product Code
OLI
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More FDA Info for this Product Code
Date Received
03/30/2016
Decision Date
09/23/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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