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510(k) K111405

BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, by Hangzhou Bever Medical Devices Co., Ltd. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2012
Date Received
May 19, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Hangzhou Bever Medical Devices Co., Ltd.

  • K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to (November 27, 2019)
  • K111406 — BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDO (July 19, 2012)
  • K111401 — BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE (July 19, 2012)

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