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FDA 510(k) Application Details - K973059
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K973059
Device Name
Polymer Patient Examination Glove
Applicant
SRI JOHANI SDN. BHD.
LOT PT 7178, BALAKONG N/V,
SERI KEMBANGAN
SELANGOR 43300 MY
Other 510(k) Applications for this Company
Contact
LIM LEE AIK
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
08/18/1997
Decision Date
11/07/1997
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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