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FDA 510(k) Application Details - K102666
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K102666
Device Name
Drape, Surgical
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
BLDG 300, #1093
ROSWELL, GA 30076-2199 US
Other 510(k) Applications for this Company
Contact
MARCIA JOHNSON
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
09/15/2010
Decision Date
11/09/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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