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510(k) K191827

Sunmed Disposable Angio-Closure Pads by Sunny Medical Device (Shenzhen) Co., Ltd. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2020
Date Received
July 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by Sunny Medical Device (Shenzhen) Co., Ltd.

  • K160190 — Sunmed Control Syringes (November 10, 2016)
  • K153685 — Sunmed Haemostatic Valves (October 13, 2016)
  • K140356 — SUMMED HIGH PRESSURE LINE (March 20, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K120119 — SUNMED GUIDE WIRE (May 11, 2012)

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