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FDA 510(k) Application Details - K092167
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K092167
Device Name
Wrap, Sterilization
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL, GA 30076 US
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Contact
THOMAS KOZMA
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
07/21/2009
Decision Date
11/02/2009
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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