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FDA 510(k) Application Details - K093593
Device Classification Name
More FDA Info for this Device
510(K) Number
K093593
Device Name
CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO
Applicant
MEDTRADE PRODUCTS LIMITED
ELECTRA HOUSE
CREW BUSINESS PARK
CREWE, CHESHIRE CWI 6GL GB
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Contact
JONATHAN RANFIELD
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2009
Decision Date
01/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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