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FDA 510(k) Application Details - K202447
Device Classification Name
Gown, Surgical
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510(K) Number
K202447
Device Name
Gown, Surgical
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
878.4040
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Classification Product Code
FYA
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More FDA Info for this Product Code
Date Received
08/26/2020
Decision Date
04/02/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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