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FDA 510(k) Application Details - K172954
Device Classification Name
Gown, Surgical
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510(K) Number
K172954
Device Name
Gown, Surgical
Applicant
Medline Industries, Inc.
3 Lakes Drive
Northfield, IL 60093 US
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Contact
Pauline Maralit
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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
09/26/2017
Decision Date
06/15/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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