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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 K072652
Device Name ENTERAL FEEDING SPIKE ADAPTER
Applicant
CEDIC S.R.L.
VIA LIBERAZIONE, 63/9
PESCHIERA BORROMEO MILAN(LOMB),  IT 20068
Applicant Contact GIANCARLO GAGLIARDONI
Correspondent
CEDIC S.R.L.
VIA LIBERAZIONE, 63/9
PESCHIERA BORROMEO MILAN(LOMB),  IT 20068
Correspondent Contact GIANCARLO GAGLIARDONI
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/20/2007
Decision Date 01/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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