Cleared Traditional

SILICONE PUNCTAL PLUG

K980437 · Oasis Medical, Inc. · Ophthalmic
Apr 1998
Decision
85d
Days
—
Risk

About This 510(k) Submission

K980437 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 April 30, 1998, 85 days after receiving the submission on February 4, 1998. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K980437 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1998
Decision Date April 30, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LZU — Plug, Punctum
Device Class —

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