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FDA 510(k) Application Details - K101801
Device Classification Name
More FDA Info for this Device
510(K) Number
K101801
Device Name
MONICA AN24
Applicant
MONICA HEALTHCARE
PENNYFOOT STREET
NOTTINGHAM NG1 1GF GB
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Contact
IAN HOW
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Regulation Number
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Classification Product Code
OSP
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More FDA Info for this Product Code
Date Received
06/28/2010
Decision Date
02/03/2011
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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