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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ureteral, Gastro-Urology
510(k) Number K043581
Device Name DUAL LUMEN CATHETER
Applicant
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact GRAHAM BAILLIE
Correspondent
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact GRAHAM BAILLIE
Regulation Number876.5130
Classification Product Code
EYB  
Date Received12/28/2004
Decision Date 03/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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