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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, Antimicrobial
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

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