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510(k) K161673

LacriPro Punctum Plug by Lacrimedics, Inc. — Product Code LZU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2016
Date Received
June 16, 2016
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 Lacrimedics, Inc.

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  • K021831 — OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-O (July 1, 2002)
  • K001737 — OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM (June 19, 2000)
  • K963501 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K963708 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K944402 — FOCOMETER (November 22, 1994)
  • K896175 — HERRICK LACRIMAL PLUG TM. (January 22, 1990)
  • K895342 — COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST (November 2, 1989)
  • K890714 — LACRIMAL EFFICIENCY TEST (TM) (May 17, 1989)

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  • K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (June 3, 2014)
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