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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name perineometer
510(k) Number K021115
Device Name GYNEFLEX
Applicant
NAISSANCE HOLDINGS, LC
800 CONNECTICUT AVENUE, N.W.
SUITE 500
WASHINGTON,  DC  20006
Applicant Contact NANCY E TAYLOR
Correspondent
NAISSANCE HOLDINGS, LC
800 CONNECTICUT AVENUE, N.W.
SUITE 500
WASHINGTON,  DC  20006
Correspondent Contact NANCY E TAYLOR
Regulation Number884.1425
Classification Product Code
HIR  
Date Received04/08/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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