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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 K993308
Device Name MENTOR EVACARE VAGINAL PESSARIES
Applicant
Mentor Corp.
201 Mentor Dr.
Santa Barbara,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
Mentor Corp.
201 Mentor Dr.
Santa Barbara,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Regulation Number884.3575
Classification Product Code
HHW  
Date Received10/04/1999
Decision Date 12/13/1999
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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