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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K873331
Device Name ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
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 Number888.1100
Classification Product Code
HRX  
Date Received08/19/1987
Decision Date 02/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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