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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Telescope, Rigid, Endoscopic
510(k) Number K031758
Device Name ACMI M4 TELESCOPES
Applicant
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact GABRIEL J MURACA
Correspondent
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact GABRIEL J MURACA
Regulation Number876.1500
Classification Product Code
FBP  
Date Received06/06/2003
Decision Date 09/02/2003
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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