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510(k) K103406

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS by Kimberly-Clark Corp. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2010
Date Received
November 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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