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FDA 510(k) Application Details - K003985
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K003985
Device Name
Polymer Patient Examination Glove
Applicant
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
Other 510(k) Applications for this Company
Contact
SUSAN D GOLDSTEIN-FALK
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
12/26/2000
Decision Date
02/09/2001
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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