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FDA 510(k) Application Details - K023910
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K023910
Device Name
Latex Patient Examination Glove
Applicant
SANREA HEALTHCARE PRIVATE LIMITED
COCHIN SPECIAL ECONOMIC ZONE
KAKKANAD, COCHIN
KERALA 682037 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
11/25/2002
Decision Date
02/11/2003
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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