Cleared Traditional

SILICONE PUNCTAL PLUG

K945906 · Oasis Medical, Inc. · Ophthalmic
Jan 1995
Decision
32d
Days
—
Risk

About This 510(k) Submission

K945906 is an FDA 510(k) clearance for the SILICONE PUNCTAL PLUG, a Plug, Punctum, submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on January 3, 1995, 32 days after receiving the submission on December 2, 1994. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K945906 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1994
Decision Date January 03, 1995
Days to Decision 32 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code LZU — Plug, Punctum
Device Class —

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