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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 Rd.,
Walsall Wood
Brownhills,  GB WS8 7DG
Applicant Contact Andrew Mullen
Correspondent
Xstrahl, Ltd.
Unit 2 Maybrook Industrial Estate, Maybrook Rd.,
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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