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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K032644
Device Name KOLPEXIN SPHERE
Applicant
Adamed , Ltd.
3432 Brookshire Dr.
Plano,  TX  75075
Applicant Contact NORMAN I BRUCKNER
Correspondent
Adamed , Ltd.
3432 Brookshire Dr.
Plano,  TX  75075
Correspondent Contact NORMAN I BRUCKNER
Regulation Number884.3575
Classification Product Code
HHW  
Date Received08/27/2003
Decision Date 05/28/2004
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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