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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(k) Number K960176
Device Name DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
Applicant
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CANSTON,  RI  02920
Applicant Contact ROBIN DRAGO
Correspondent
C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CANSTON,  RI  02920
Correspondent Contact ROBIN DRAGO
Regulation Number876.5980
Classification Product Code
FEG  
Date Received01/16/1996
Decision Date 07/24/1996
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
Recalls CDRH Recalls
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