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FDA 510(k) Application Details - K980421
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K980421
Device Name
Polymer Patient Examination Glove
Applicant
OMNIGRACE (THAILAND) LTD.
7815 VANDERBILT DRIVE NW
NORTH CANTON, OH 44720 US
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Contact
WILLIAM E PATTON
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
02/03/1998
Decision Date
03/13/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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