Cleared Traditional

K963708 - HERRICK ULTIMATE PUNCTUM PLUG
(FDA 510(k) Clearance)

Apr 1997
Decision
210d
Days
Risk

K963708 is an FDA 510(k) clearance for the HERRICK ULTIMATE PUNCTUM PLUG. This device is classified as a Plug, Punctum.

Submitted by Lacrimedics, Inc. (Rialto, US). The FDA issued a Cleared decision on April 14, 1997, 210 days after receiving the submission on September 16, 1996.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K963708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date April 14, 1997
Days to Decision 210 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LZU — Plug, Punctum
Device Class

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