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510(k) K053333

EAGLEVISION GELLANSERTS, MODEL REF 0040 by Eagle Vision, Inc. — Product Code LZU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2006
Date Received
December 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Eagle Vision, Inc.

  • K030353 — MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS (April 25, 2003)
  • K991130 — FLEXPLUG (April 20, 1999)
  • K905427 — EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG (June 6, 1991)
  • K890919 — TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (May 16, 1989)
  • K890920 — EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE (April 11, 1989)
  • K883233 — EV MONOCANALICULAR STENT (TM) (August 22, 1988)

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