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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 K210843
Device Name STAGE
Applicant
SpinTech, Inc.
30200 Telegraph Road, Suite 140
Bingham Farms,  MI  48025
Applicant Contact Kay Fuller
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received03/22/2021
Decision Date 06/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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