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510(k) K150151

SmartGownTM surgical gown by Cardinal Health 200, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2015
Date Received
January 23, 2015
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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