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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 K863853
Device Name EAZY COVERS
Applicant
Superior Medical Products
Post Office Box 71987
Marietta,  GA  30007
Applicant Contact COTTONE, JR.
Correspondent
Superior Medical Products
Post Office Box 71987
Marietta,  GA  30007
Correspondent Contact COTTONE, JR.
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/02/1986
Decision Date 03/06/1987
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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