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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Endoscopic, Without Audio
510(k) Number K990154
Device Name KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
Applicant
KARL STORZ IMAGING, INC.
175 CREMONA DR.
GOLETA,  CA  93117
Applicant Contact TERRY FERNANDEZ
Correspondent
KARL STORZ IMAGING, INC.
175 CREMONA DR.
GOLETA,  CA  93117
Correspondent Contact TERRY FERNANDEZ
Regulation Number878.4160
Classification Product Code
FWF  
Date Received01/19/1999
Decision Date 06/01/1999
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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