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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, nasogastric
510(k) Number K961711
Device Name ASPISAFE GASTRIC TUBE
Applicant
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number876.5980
Classification Product Code
BSS  
Date Received05/02/1996
Decision Date 06/11/1997
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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