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FDA 510(k) Application Details - K014134
Device Classification Name
Patient Examination Glove
More FDA Info for this Device
510(K) Number
K014134
Device Name
Patient Examination Glove
Applicant
SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD.
198 AVENUE DE LA D'EMERALD
SPARKS, NV 89434-9550 US
Other 510(k) Applications for this Company
Contact
JANNA P TUCKER
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
FMC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2001
Decision Date
01/22/2002
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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