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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 K092278
Device Name GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
Applicant
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact GRAHAM A.L. BAILLIE
Correspondent
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact GRAHAM A.L. BAILLIE
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/28/2009
Decision Date 09/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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