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510(k) K963434

VISCOUS FLUID SYSTEM by Escalon Trek Medical — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1996
Date Received
August 30, 1996
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

Other clearances by Escalon Trek Medical

  • K963417 — VITLITE (TR7700) (December 20, 1996)
  • K924999 — AUTOPOLE REGULATOR SYSTEM (December 24, 1992)

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