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FDA 510(k) Application Details - K093169
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K093169
Device Name
Gown, Surgical
Applicant
A PLUS INTERNATIONAL, INC.
5138 EUCALYPTUS AVE.
CHINO, CA 91710 US
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Contact
SOLOMON CHEN
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FYA
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More FDA Info for this Product Code
Date Received
10/07/2009
Decision Date
11/12/2009
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
Y
Expedited Review
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