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FDA 510(k) Application Details - K974371
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K974371
Device Name
Latex Patient Examination Glove
Applicant
CLK INTL., INC.
28 EAST BROADWAY, 2ND FL.
NEW YORK, NY 10002 US
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Contact
GEORGE Q KUO
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
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More FDA Info for this Product Code
Date Received
11/20/1997
Decision Date
04/21/1998
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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