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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 K941363
Device Name PHANTOM
Applicant
Dynarad Corp.
19 Jefryn Blvd. W.
Deer Park,  NY  11729
Applicant Contact RAYMOND MANEZ
Correspondent
Dynarad Corp.
19 Jefryn Blvd. W.
Deer Park,  NY  11729
Correspondent Contact RAYMOND MANEZ
Regulation Number892.1720
Classification Product Code
IZL  
Date Received03/21/1994
Decision Date 07/20/1994
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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