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FDA 510(k) Application Details - K112924
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K112924
Device Name
Polymer Patient Examination Glove
Applicant
RIVERSTONE RESOURCES SDN. BHD.
LOT 56, NO. 15, JALAN JASMIN 2
BUKIT BERUNTUNG, SELANGOR 48300 MY
Other 510(k) Applications for this Company
Contact
CHONG CHU MEE
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
10/03/2011
Decision Date
05/02/2012
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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