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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, Fluoroscopic, Image-Intensified
510(k) Number K884578
Device Name POLARIX 2 AND POLARIX 2E
Applicant
Dyna-Med
3706-B E. Rio Grande
Victoria,  TX  77901
Applicant Contact THOMAS, JR
Correspondent
Dyna-Med
3706-B E. Rio Grande
Victoria,  TX  77901
Correspondent Contact THOMAS, JR
Regulation Number892.1650
Classification Product Code
JAA  
Date Received11/01/1988
Decision Date 02/09/1989
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
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