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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 K872711
Device Name MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
Applicant
Directed Energy, Inc.
11661 San Vicente Blvd.
Suite 203
Los Angeles,  CA  90049
Applicant Contact EDWARD JOHANSEN
Correspondent
Directed Energy, Inc.
11661 San Vicente Blvd.
Suite 203
Los Angeles,  CA  90049
Correspondent Contact EDWARD JOHANSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/07/1987
Decision Date 09/28/1987
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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