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FDA 510(k) Application Details - K042527
Device Classification Name
Spatula, Cervical, Cytological
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510(K) Number
K042527
Device Name
Spatula, Cervical, Cytological
Applicant
MEDICAL ACTION INDUSTRIES, INC.
25 HEYWOOD RD.
ARDEN, NC 28704 US
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Contact
ROBIN BLANKENBAKER
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
09/17/2004
Decision Date
11/08/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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