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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 K990593
Device Name PELVX INCONTINENCE DISH, MODEL 301-306
Applicant
DESCHUTES MEDICAL PRODUCTS, INC.
1011 S.W. EMKAY DR., SUITE 104
BEND,  OR  97702
Applicant Contact DENISE BESTWICK
Correspondent
DESCHUTES MEDICAL PRODUCTS, INC.
1011 S.W. EMKAY DR., SUITE 104
BEND,  OR  97702
Correspondent Contact DENISE BESTWICK
Regulation Number884.3575
Classification Product Code
HHW  
Date Received02/24/1999
Decision Date 05/24/1999
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
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