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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 K984349
Device Name DORNIER MEDILAS R
Applicant
Dornier
1155 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact CAROL WERNECKE
Correspondent
Dornier
1155 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact CAROL WERNECKE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/04/1998
Decision Date 02/04/1999
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
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