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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K912531
Device Name IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS
Applicant
Innovative Medical Devices, Inc.
1637 Grand Rd.
Mountain View,  CA  94040
Applicant Contact ALAN PECK
Correspondent
Innovative Medical Devices, Inc.
1637 Grand Rd.
Mountain View,  CA  94040
Correspondent Contact ALAN PECK
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCT  
Date Received06/07/1991
Decision Date 09/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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