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FDA 510(k) Application Details - K100846
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K100846
Device Name
Mask, Surgical
Applicant
INTERNATIONAL MEDSURG CONNECTION
935 N PLUM GROVE RD, STE F
SCHAUMBURG, IL 60173 US
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Contact
PETER KIM
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
03/25/2010
Decision Date
08/16/2010
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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