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FDA 510(k) Application Details - K002818
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K002818
Device Name
Polymer Patient Examination Glove
Applicant
SIAM SEMPERMED CORP. LTD.
30798 US HWY 19 NORTH
PALM HARBOR, FL 34684 US
Other 510(k) Applications for this Company
Contact
WILLIAM HARRIS
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2000
Decision Date
11/29/2000
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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