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510(k) K140539

AERO BLUE PERFORMANCE SURGICAL GOWN by Kimberly-Clark Corporation — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2014
Date Received
March 4, 2014
Clearance Type
Abbreviated
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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