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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 K981286
Device Name SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
Applicant
ARMM, INC.
17744 SAMPSON LN.
HUNTINGTON BEACH,  CA  92647
Applicant Contact ROGER WOOD
Correspondent
ARMM, INC.
17744 SAMPSON LN.
HUNTINGTON BEACH,  CA  92647
Correspondent Contact ROGER WOOD
Regulation Number876.5980
Classification Product Code
KDH  
Date Received04/08/1998
Decision Date 06/19/1998
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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