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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, feeding
510(k) Number K905677
Device Name JEJUNO-CATH KIT
Applicant
HEALTH IMPROVEMENT ASSOC.
12555 WEST FREELAND RD.
FREELAND,  MI  48623
Applicant Contact ALEXANDER BOMMARITO
Correspondent
HEALTH IMPROVEMENT ASSOC.
12555 WEST FREELAND RD.
FREELAND,  MI  48623
Correspondent Contact ALEXANDER BOMMARITO
Regulation Number876.5980
Classification Product Code
FPD  
Date Received12/19/1990
Decision Date 08/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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