FDA 510(k) Application Details - K961711

Device Classification Name Tube, Nasogastric

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510(K) Number K961711
Device Name Tube, Nasogastric
Applicant B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM, PA 18018 US
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Contact MARK S ALSBERGE
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Regulation Number 876.5980

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Classification Product Code BSS
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Date Received 05/02/1996
Decision Date 06/11/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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