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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 K934514
Device Name CATCH AND HOLD OPTION FOR INSTASCAN
Applicant
Advanced Nmr Systems, Inc.
46 Jonspin Rd.
Wilmington,  MA  01887
Applicant Contact DENNIS ANGWIN
Correspondent
Advanced Nmr Systems, Inc.
46 Jonspin Rd.
Wilmington,  MA  01887
Correspondent Contact DENNIS ANGWIN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/15/1993
Decision Date 06/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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