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FDA 510(k) Application Details - K141438
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K141438
Device Name
Drape, Surgical
Applicant
WHITNEY MEDICAL SOLUTIONS
6153C WEST MULFORD STREET
NILES, IL 60714 US
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Contact
SAAGAR PATEL
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
05/30/2014
Decision Date
08/14/2014
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
Y
Expedited Review
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