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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Nasogastric
510(k) Number K905573
Device Name XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
Applicant
Zeon Medical Corp.
50 Main St.
White Plains,  NY  10606
Applicant Contact BURNS, JR.
Correspondent
Zeon Medical Corp.
50 Main St.
White Plains,  NY  10606
Correspondent Contact BURNS, JR.
Regulation Number876.5980
Classification Product Code
BSS  
Date Received12/12/1990
Decision Date 06/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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