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FDA 510(k) Application Details - K071022
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K071022
Device Name
Vinyl Patient Examination Glove
Applicant
GLORMED COLOMBIA S.A.
2700 NORTH MAIN STREET
SUITE 506
SANTA ANA, CA 92705 US
Other 510(k) Applications for this Company
Contact
SAM KAO
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
04/11/2007
Decision Date
07/05/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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