FDA 510(k) Application Details - K160880

Device Classification Name

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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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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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