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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 K124030
Device Name COOK HOLMIUM LASER FIBER
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact CONNIE RICE
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact CONNIE RICE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/28/2012
Decision Date 07/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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