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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K812017
Device Name X-RAY DETECTABLE BAND
Applicant
ISRAMED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ISRAMED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4450
Classification Product Code
GDY  
Date Received07/17/1981
Decision Date 11/20/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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