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510(k) K946016

IVALON OPHTHALMIC SPONGE by Ivalon — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1995
Date Received
December 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Ivalon

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K913556 — IVALON EMBOLIZATION PARTICLES (April 13, 1994)

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