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FDA 510(k) Application Details - K112012
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K112012
Device Name
Polymer Patient Examination Glove
Applicant
UG HEALTHCARE (USA), INC.
1565 SUNFLOWER AVE.
COSTA MESA, CA 92626 US
Other 510(k) Applications for this Company
Contact
KEN STANTON
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
07/13/2011
Decision Date
03/21/2012
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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