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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K991228
Device Name DCI ENDOSCOPE
Applicant
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact KEVIN KENNAN
Correspondent
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact KEVIN KENNAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/12/1999
Decision Date 06/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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