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FDA 510(k) Application Details - K092580
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K092580
Device Name
Mask, Surgical
Applicant
TIDI PRODUCTS,LLC
570 ENTERPRISE DR.
NEENAH, WI 54956 US
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Contact
DION J BRANDT
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2009
Decision Date
02/23/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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