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FDA 510(k) Application Details - K112796
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K112796
Device Name
Gown, Surgical
Applicant
COBES INDUSTRIES CO., LTD.
3500 SOUTH DUPONT HIGHWAY
DOVER, DE 19901 US
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Contact
LEON LU
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
09/26/2011
Decision Date
09/12/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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