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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K031001
Device Name ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
Applicant
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact GABRIEL J MURACA
Correspondent
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact GABRIEL J MURACA
Regulation Number876.4300
Classification Product Code
FAS  
Date Received03/31/2003
Decision Date 05/21/2003
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
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