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FDA 510(k) Application Details - K043369
Device Classification Name
Spatula, Cervical, Cytological
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510(K) Number
K043369
Device Name
Spatula, Cervical, Cytological
Applicant
ROVERS MEDICAL DEVICES B.V.
LEKSTRAAT 10
OSS 5347 KV NL
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Contact
IR. M.D. ZWART
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HHT
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More FDA Info for this Product Code
Date Received
12/08/2004
Decision Date
02/02/2005
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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