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FDA 510(k) Application Details - K042817
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K042817
Device Name
Polymer Patient Examination Glove
Applicant
ANSELL HEALTHCARE PRODUCTS, INC.
1635 INDUSTRIAL ROAD
DOTHAN, AL 36303 US
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Contact
LON D MCLLVAIN
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
10/12/2004
Decision Date
12/06/2004
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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