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FDA 510(k) Application Details - K991153
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K991153
Device Name
Latex Patient Examination Glove
Applicant
MEDTEXX INDUSTRIES (THAI) CO. LTD.
200 MU-4, TAMBOL TACHANG
PO BOX 38 HATYAI
AMPHUR BANGKLAM SONGKHLA 90110 TH
Other 510(k) Applications for this Company
Contact
STEPHEN TAN CKENG KIM
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/1999
Decision Date
06/21/1999
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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