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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 K083500
Device Name MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
Applicant
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact THERON GOBER
Correspondent
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact THERON GOBER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/25/2008
Decision Date 02/12/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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