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FDA 510(k) Application Details - K103406
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K103406
Device Name
Gown, Surgical
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
BLDG 300, #1093
ROSWELL, GA 30076-2199 US
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Contact
DAVID M LEE
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2010
Decision Date
12/23/2010
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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