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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K052044
Device Name ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
Applicant
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact TERRENCE E SULLIVAN
Correspondent
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact TERRENCE E SULLIVAN
Regulation Number876.1500
Classification Product Code
FGB  
Date Received07/28/2005
Decision Date 08/16/2005
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
Predetermined Change
Control Plan Authorized		 No
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