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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K874936
Device Name MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
Applicant
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Applicant Contact DONNA PLANTE
Correspondent
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Correspondent Contact DONNA PLANTE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/04/1987
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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