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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter (gastric, colonic, etc.), irrigation and aspiration
510(k) Number K971259
Device Name COMBIPORT FLUID LAVAGE DEVICE
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109 -9341
Applicant Contact MARK S ALSBERGE
Correspondent
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109 -9341
Correspondent Contact MARK S ALSBERGE
Regulation Number876.5980
Classification Product Code
KDH  
Date Received04/04/1997
Decision Date 10/27/1997
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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