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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Abortion, Vacuum
510(k) Number K171440
Device Name Berkeley VC-10 Vacuum Curettage System
Applicant
Gyrus Acmi
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact Christina Flores
Correspondent
Gyrus Acmi
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Christina Flores
Regulation Number884.5070
Classification Product Code
HHI  
Subsequent Product Code
HHK  
Date Received05/16/2017
Decision Date 09/29/2017
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
Recalls CDRH Recalls
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