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510(k) K050716

ISCIENCE SURGICAL VISCOINJECTOR by Iscience Surgical Corporation — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2005
Date Received
March 21, 2005
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 Iscience Surgical Corporation

  • K041108 — ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (June 22, 2004)

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