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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name curette, suction, endometrial (and accessories)
510(k) Number K051294
Device Name FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
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 Number884.1175
Classification Product Code
HHK  
Date Received05/18/2005
Decision Date 12/21/2005
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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