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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K142638
Device Name ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
Applicant
InnovaQuartz LLC
23030 North 15th Ave
Phoenix,  AZ  85027 -1315
Applicant Contact Stephen Griffin
Correspondent
InnovaQuartz LLC
23030 North 15th Ave
Phoenix,  AZ  85027 -1315
Correspondent Contact Stephen Griffin
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/17/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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