FDA 510(k) Application Details - K020512

Device Classification Name Pessary, Vaginal

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510(K) Number K020512
Device Name Pessary, Vaginal
Applicant MEDICAL TECHNOLOGY AND INNOVATIONS, INC.
1072 N.W. HIGH POINT DR.
LEE'S SUMMIT, MO 64081 US
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Contact LARRY W JAMES
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Regulation Number 884.3575

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Classification Product Code HHW
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Date Received 02/15/2002
Decision Date 05/16/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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