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510(k) K991130

FLEXPLUG by Eagle Vision, Inc. — Product Code LZU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1999
Date Received
April 2, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • 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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