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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K030960
Device Name ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
Applicant
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact John DeLucia
Correspondent
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact John DeLucia
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Codes
FGA   FWF  
Date Received03/27/2003
Decision Date 07/16/2003
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
Predetermined Change
Control Plan Authorized		 No
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