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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, therapeutic, x-ray
510(k) Number K172080
Device Name Photoelectric Therapy System
Applicant
Xstrahl Ltd.
Unit 2 Maybrook Industrial Estate, Maybrook Road,
Walsall Wood
Brownhills,  GB WS8 7DG
Applicant Contact Andrew Mullen
Correspondent
Xstrahl Ltd.
Unit 2 Maybrook Industrial Estate, Maybrook Road,
Walsall Wood
Brownhills,  GB WS8 7DG
Correspondent Contact Andrew Mullen
Regulation Number892.5900
Classification Product Code
JAD  
Date Received07/10/2017
Decision Date 09/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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