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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K991895
Device Name RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
Applicant
Ri Mos. S.R.L.
100 Main St.
Suite 120
Concord,  MA  01742
Applicant Contact JAMES DELANEY
Correspondent
Ri Mos. S.R.L.
100 Main St.
Suite 120
Concord,  MA  01742
Correspondent Contact JAMES DELANEY
Regulation Number884.1175
Classification Product Code
HHK  
Date Received06/03/1999
Decision Date 08/12/1999
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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