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FDA 510(k) Application Details - K120798
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K120798
Device Name
Vinyl Patient Examination Glove
Applicant
CANOPUS MEDICAL SUPPLY CO., LTD.
18709 GREEN BAT DR.,
ROWLAND HIGHS, CA 91748 US
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Contact
GLORIA CHANG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
03/15/2012
Decision Date
05/14/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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