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FDA 510(k) Application Details - K001216
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K001216
Device Name
Latex Patient Examination Glove
Applicant
FITCO DIPPED PRODUCTS PVT. LTD
14-A COCHIN EXPORT PROCESSING
ZONE, KAKKANAND, COCHIN
KERALA 682 030 IN
Other 510(k) Applications for this Company
Contact
JOSEPH J E PEREIRA
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
04/14/2000
Decision Date
04/28/2000
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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