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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 K950862
Device Name KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES
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 Number876.1500
Classification Product Code
GCJ  
Date Received02/27/1995
Decision Date 05/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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