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FDA 510(k) Application Details - K033086
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K033086
Device Name
Polymer Patient Examination Glove
Applicant
PT. MEDISAFE TECHNOLOGIES
GG. TAMBAK REJO
DESA BUNTU BEDIMBAR
TANJUNG MORAWA 20362 ID
Other 510(k) Applications for this Company
Contact
ANIL TANEJA
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
09/29/2003
Decision Date
02/26/2004
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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