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FDA 510(k) Application Details - K100208
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K100208
Device Name
Drape, 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
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2010
Decision Date
04/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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