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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 K962613
Device Name DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
Applicant
Gulmay Medical , Ltd.
Unit 7, Shepperton Business
Park, Govett Ave.
Shepperton, Middlesex,  GB TW17 8BA
Applicant Contact G. CONDLIFFE
Correspondent
Gulmay Medical , Ltd.
Unit 7, Shepperton Business
Park, Govett Ave.
Shepperton, Middlesex,  GB TW17 8BA
Correspondent Contact G. CONDLIFFE
Regulation Number892.5900
Classification Product Code
JAD  
Date Received07/03/1996
Decision Date 09/27/1996
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
Recalls CDRH Recalls
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