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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, mobile
510(k) Number K170607
Device Name !M1
Applicant
Solutions For Tomorrow AB
Saxagardsv. 4
Vackelsang,  SE 36251
Applicant Contact Martin Yngvesson
Correspondent
Solutions For Tomorrow AB
Saxagardsv. 4
Vackelsang,  SE 36251
Correspondent Contact Martin Yngvesson
Regulation Number892.1720
Classification Product Code
IZL  
Date Received03/01/2017
Decision Date 07/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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