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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K022480
Device Name ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
Applicant
Acmi Corporation
136 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact JOHN A DELUCIA
Correspondent
Acmi Corporation
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact JOHN A DELUCIA
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HGI  
Date Received07/26/2002
Decision Date 08/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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