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FDA 510(k) Application Details - K113639
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K113639
Device Name
Polymer Patient Examination Glove
Applicant
AMERCARE, INC.
611 W. 5TH STREET
THIRD FLOOR
AUSTIN, TX 78701 US
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Contact
ANDREW LOWERY
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
12/09/2011
Decision Date
05/08/2012
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
N
Expedited Review
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