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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sampler, endocervical
510(k) Number K060320
Device Name FEMECC ENDOCERVICAL CURETTE
Applicant
FEMSPEC L.L.C.
1530 HOLCOMB STREET
PORT TOWNSEND,  WA  98368
Applicant Contact CARL YOUNGMANN
Correspondent
FEMSPEC L.L.C.
1530 HOLCOMB STREET
PORT TOWNSEND,  WA  98368
Correspondent Contact CARL YOUNGMANN
Regulation Number884.1050
Classification Product Code
PCF  
Date Received02/08/2006
Decision Date 07/28/2006
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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