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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 K923168
Device Name DUAL PORT ENTERAL Y-ADAPTOR
Applicant
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Applicant Contact JOHN LAEMMAR
Correspondent
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Correspondent Contact JOHN LAEMMAR
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/29/1992
Decision Date 06/17/1994
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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