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FDA 510(k) Application Details - K202179
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K202179
Device Name
Vinyl Patient Examination Glove
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093 US
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Contact
Adam Ostrower
Other 510(k) Applications for this Contact
Regulation Number
880.6250
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Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
08/04/2020
Decision Date
10/26/2020
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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