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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 K020512
Device Name MTI ST#1 SILICONE PESSARY
Applicant
MEDICAL TECHNOLOGY AND INNOVATIONS, INC.
1072 N.W. HIGH POINT DR.
LEE'S SUMMIT,  MO  64081
Applicant Contact LARRY W JAMES
Correspondent
MEDICAL TECHNOLOGY AND INNOVATIONS, INC.
1072 N.W. HIGH POINT DR.
LEE'S SUMMIT,  MO  64081
Correspondent Contact LARRY W JAMES
Regulation Number884.3575
Classification Product Code
HHW  
Date Received02/15/2002
Decision Date 05/16/2002
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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