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510(k) K160190

Sunmed Control Syringes by Sunny Medical Device (Shenzhen) Co., Ltd. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2016
Date Received
January 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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

  • K191827 — Sunmed Disposable Angio-Closure Pads (March 16, 2020)
  • 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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