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FDA 510(k) Application Details - K092000
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K092000
Device Name
Vinyl Patient Examination Glove
Applicant
SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.
12390 EAST END AVE.
CHINO, CA 91710 US
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Contact
JOHN ZHAO
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/02/2009
Decision Date
09/18/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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