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FDA 510(k) Application Details - K070639
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K070639
Device Name
Polymer Patient Examination Glove
Applicant
SIAM SEMPERMED CORP. LTD.
13900 49TH STREET NORTH
CLEARWATER, FL 33762 US
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Contact
WILLIAM E HARRIS
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Regulation Number
880.6250
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Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
03/07/2007
Decision Date
06/15/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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