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FDA 510(k) Application Details - K053259
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K053259
Device Name
Vinyl Patient Examination Glove
Applicant
PRACTICAL PROTECTIVE PLASTIC MANUFACTORY LTD.
1800 CENTURY PARK EAST
SUITE 600
CENTURY CITY, CA 90067 US
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Contact
GEORGE SU
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Regulation Number
880.6250
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Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
11/22/2005
Decision Date
01/18/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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