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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tenaculum, Uterine
510(k) Number K062563
Device Name FEMTEN CERVICAL TENACULUM
Applicant
FEM SUITE, L.L.C.
1530 HOLCOMB STREET
PORT TOWNSEND,  WA  98368
Applicant Contact CARL YOUNGMANN
Correspondent
FEM SUITE, L.L.C.
1530 HOLCOMB STREET
PORT TOWNSEND,  WA  98368
Correspondent Contact CARL YOUNGMANN
Regulation Number884.4530
Classification Product Code
HDC  
Date Received08/31/2006
Decision Date 05/18/2007
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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