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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 K981856
Device Name MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
Applicant
GREATBATCH SCIENTIFIC
9645 WEHRLE DR.
CLARENCE,  NY  14031 -1899
Applicant Contact GARY J SFEIR
Correspondent
GREATBATCH SCIENTIFIC
9645 WEHRLE DR.
CLARENCE,  NY  14031 -1899
Correspondent Contact GARY J SFEIR
Regulation Number876.1500
Classification Product Code
FET  
Date Received05/27/1998
Decision Date 07/29/1998
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
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