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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 K111226
FOIA Releasable 510(k) K111226
Device Name ENDOSCOUT TRACKING SYSTEM
Applicant
ROBIN MEDICAL, INC.
56B SHADOWBROOK DRIVE
hudson,  NH  03051
Applicant Contact raymond kelly
Correspondent
ROBIN MEDICAL, INC.
56B SHADOWBROOK DRIVE
hudson,  NH  03051
Correspondent Contact raymond kelly
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/02/2011
Decision Date 07/01/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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