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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 K001243
Device Name DORNIER MEDILAS H
Applicant
Dornier Surgical Products, Inc.
8623 N. Lagoon Dr.
Suite C3
Panama Cyt Bch,  FL 
Applicant Contact JOE D BROWN
Correspondent
Dornier Surgical Products, Inc.
8623 N. Lagoon Dr.
Suite C3
Panama Cyt Bch,  FL 
Correspondent Contact JOE D BROWN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/18/2000
Decision Date 05/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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