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FDA 510(k) Application Details - K062688
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K062688
Device Name
Latex Patient Examination Glove
Applicant
UG HEALTHCARE (USA), INC.
2420 CARSON ST., SUITE 125
TORRANCE, CA 90501-3163 US
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Contact
KENNETH J STANTON
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
09/08/2006
Decision Date
11/30/2006
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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