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510(k) K141606

SURGICAL GOWN by Cobes Industries Co., Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2014
Date Received
June 16, 2014
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.

  • K112796 — SURGICAL GOWN (EO STERILIZED) (September 12, 2013)
  • K112378 — COBES SURGICAL DRAPE (May 8, 2012)

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