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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Traction
510(k) Number K884340
Device Name AMX-110, AMX-II AND AMX-III
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 Number890.5925
Classification Product Code
ILZ  
Date Received10/14/1988
Decision Date 01/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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