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510(k) K211680

Streamline Surgical System by New World Medical, Inc. — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2021
Date Received
June 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Ophthalmic
Device Class
Class II
Regulation Number
880.5725
Review Panel
OP
Submission Type

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Other clearances for product code MRH

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  • K213173 — TrabEx Pro (June 8, 2022)
  • K212797 — iPrime Viscodelivery System (January 6, 2022)
  • K202678 — OMNI Surgical System (March 1, 2021)
  • K201953 — OMNI PLUS Surgical System (August 11, 2020)
  • K173332 — OMNI Surgical System (December 21, 2017)
  • K171905 — VISCO 360 Viscosurgical System (July 27, 2017)
  • K143205 — Viscoelastic Injector (December 5, 2014)
  • K132494 — VISCOELASTIC INJECTOR (October 22, 2013)