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FDA 510(k) Application Details - K993247
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K993247
Device Name
Polymer Patient Examination Glove
Applicant
JDA INTL., INC.
2919 EAST PHILADELPHIA ST.
ONTARIO, CA 91761 US
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Contact
KEIDY GU
Other 510(k) Applications for this Contact
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
09/28/1999
Decision Date
11/05/1999
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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