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510(k) K211210

Sterile Auto-Disable Syringes with/without Needle for Single Use by Azur Medical Company, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2022
Date Received
April 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Azur Medical Company, Inc.

  • K231719 — Medical Surgical Mask (March 19, 2024)
  • K211214 — Sterile Hypodermic Needles for Single Use (October 14, 2021)
  • K211211 — Sterile syringes for single use with/without needle (October 7, 2021)

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  • K251350 — BD Plastipak™ Syringe (July 29, 2025)