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FDA 510(k) Application Details - K960469
Device Classification Name
Spatula, Cervical, Cytological
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510(K) Number
K960469
Device Name
Spatula, Cervical, Cytological
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER, IN 47460 US
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Contact
TAMMY BACON
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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
02/01/1996
Decision Date
03/14/1996
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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