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FDA 510(k) Application Details - K200960
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K200960
Device Name
Polymer Patient Examination Glove
Applicant
Medline Industires, 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
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
04/10/2020
Decision Date
07/13/2020
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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