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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stent, vaginal
510(k) Number K983045
Device Name AMIELLE
Applicant
Owen Mumford USA, Inc.
849 PICKENS INDUSTRIAL DR.
SUITE 14
MARIETTA,  GA  30062
Applicant Contact ROBERT E SHAW
Correspondent
Owen Mumford USA, Inc.
849 PICKENS INDUSTRIAL DR.
SUITE 14
MARIETTA,  GA  30062
Correspondent Contact ROBERT E SHAW
Regulation Number884.3900
Classification Product Code
KXP  
Date Received09/01/1998
Decision Date 11/25/1998
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
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