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510(k) K112378

COBES SURGICAL DRAPE by Cobes Industries Co., Ltd. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2012
Date Received
August 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Cobes Industries Co., Ltd.

  • K141606 — SURGICAL GOWN (November 17, 2014)
  • K112796 — SURGICAL GOWN (EO STERILIZED) (September 12, 2013)

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  • K163556 — MediClear PreOp (September 14, 2017)
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  • K140195 — SURGICAL DRAPE (September 10, 2014)
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  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)