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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K033485
FOIA Releasable 510(k) K033485
Device Name ENDOSCOUT
Applicant
Robin Medical, Inc.
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
Robin Medical, Inc.
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/04/2003
Decision Date 04/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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