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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 K022544
Device Name DORNIER MEDILAS H LASER FIBER CABLES
Applicant
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact Tim Thomas
Correspondent
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact Tim Thomas
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/01/2002
Decision Date 08/21/2002
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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