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FDA 510(k) Application Details - K060320
Device Classification Name
More FDA Info for this Device
510(K) Number
K060320
Device Name
FEMECC ENDOCERVICAL CURETTE
Applicant
FEMSPEC L.L.C.
1530 HOLCOMB STREET
PORT TOWNSEND, WA 98368 US
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Contact
CARL YOUNGMANN
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Regulation Number
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Classification Product Code
PCF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2006
Decision Date
07/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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