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510(k) K141438

WHITNEY MEDICAL SOLUTIONS ESHIELD by Whitney Medical Solutions — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2014
Date Received
May 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

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