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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 K862855
Device Name CRAIG NASO-GASTRIC TUBE HOLDER
Applicant
HENLEY INTL.
10518 KINGHURST
HOUSTON,  TX  77099
Applicant Contact ERNEST J HENLEY
Correspondent
HENLEY INTL.
10518 KINGHURST
HOUSTON,  TX  77099
Correspondent Contact ERNEST J HENLEY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/29/1986
Decision Date 11/04/1986
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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