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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscopy Kit
510(k) Number K955717
Device Name ENDOSCOPE INTRODUCER KIT
Applicant
Mitsubishi Cable America, Inc.
10551 Wulff Dr.
Villa Park,  CA  92667
Applicant Contact RONALD J EHMSEN
Correspondent
Mitsubishi Cable America, Inc.
10551 Wulff Dr.
Villa Park,  CA  92667
Correspondent Contact RONALD J EHMSEN
Regulation Number876.1500
Classification Product Code
FDE  
Date Received12/18/1995
Decision Date 04/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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