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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 K871848
Device Name NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP
Applicant
PANAMEDIX, INC.
1308-E LOGAN AVE.
COSTA MESA,  CA  92626
Applicant Contact CARL W JOHNSTON
Correspondent
PANAMEDIX, INC.
1308-E LOGAN AVE.
COSTA MESA,  CA  92626
Correspondent Contact CARL W JOHNSTON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/12/1987
Decision Date 02/03/1988
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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