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510(k) K120045

EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV by Exact Medical Manufacturing, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2012
Date Received
January 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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