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FDA 510(k) Application Details - K984309
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K984309
Device Name
Polymer Patient Examination Glove
Applicant
SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD.
LOT 44, 45 & 86, BAKAR ARANG
INDUSTRIAL ESTATE
SUNGAI PETANI, KEDAH 08000 MY
Other 510(k) Applications for this Company
Contact
HIDEAKI OCHIAL
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
12/02/1998
Decision Date
02/12/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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