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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name speculum, vaginal, nonmetal
510(k) Number K052192
Device Name FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
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 Number884.4530
Classification Product Code
HIB  
Date Received08/11/2005
Decision Date 02/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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