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510(k) K112796

SURGICAL GOWN (EO STERILIZED) by Cobes Industries Co., Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2013
Date Received
September 26, 2011
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

Other clearances by Cobes Industries Co., Ltd.

  • K141606 — SURGICAL GOWN (November 17, 2014)
  • K112378 — COBES SURGICAL DRAPE (May 8, 2012)

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