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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 K123385
Device Name MEDILAS H LASER FIBERS
Applicant
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact JOHN HOFFER
Correspondent
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact JOHN HOFFER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/02/2012
Decision Date 12/14/2012
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
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