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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 K030935
Device Name BERKELEY V-10 VACUUM CURETTAGE SYSTEM
Applicant
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact FRANK FUCILE
Correspondent
Acmi Corporation
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact FRANK FUCILE
Regulation Number884.5070
Classification Product Code
HHI  
Subsequent Product Code
HHK  
Date Received03/25/2003
Decision Date 06/23/2003
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
Recalls CDRH Recalls
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