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FDA 510(k) Application Details - K112805
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K112805
Device Name
Wrap, Sterilization
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
BUILDING 300
ROSWELL, GA 30076 US
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Contact
Brenda Shelkey
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2011
Decision Date
06/22/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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