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FDA 510(k) Application Details - K083234
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K083234
Device Name
Drape, Surgical
Applicant
KIMBERLY-CLARK CORP.
172 CONDUCTOR DRIVE
DAWSONVILLE, GA 30534 US
Other 510(k) Applications for this Company
Contact
LISA PEACOCK
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
11/03/2008
Decision Date
03/25/2009
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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