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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 K881014
Device Name THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3578
Applicant Contact ROBERT R GIORGINI
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3578
Correspondent Contact ROBERT R GIORGINI
Regulation Number878.4160
Classification Product Code
FWF  
Date Received03/10/1988
Decision Date 04/14/1988
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
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