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FDA 510(k) Application Details - K982611
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K982611
Device Name
Latex Patient Examination Glove
Applicant
UNIJECT GLOVES PCL
2920 MUMPHREY DR.
CHALMETTE, LA 70043 US
Other 510(k) Applications for this Company
Contact
SARA JOHNSON
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
06/26/1998
Decision Date
11/02/1998
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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