FDA 510(k) Application Details - K061589

Device Classification Name Light, Ultraviolet, Dermatological

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510(K) Number K061589
Device Name Light, Ultraviolet, Dermatological
Applicant SOLARC SYSTEMS, INC.
12 PARKER COURT
BARRIE, ONTARIO L4N 2A6 CA
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Contact BRUCE ELLIOTT
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Regulation Number 878.4630

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Classification Product Code FTC
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Date Received 06/08/2006
Decision Date 08/04/2006
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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