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FDA 510(k) Application Details - K111067
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K111067
Device Name
Gown, Surgical
Applicant
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
1340 WEST PENNSYLVANIA AVE
SAN DIEGO, CA 92103 US
Other 510(k) Applications for this Company
Contact
Glen Feye
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2011
Decision Date
08/02/2011
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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