Cleared Traditional

SOFT PLUG ABSORBABLE PLUG-SA

K013613 · Oasis Medical, Inc. · Ophthalmic
Jun 2002
Decision
234d
Days
Risk

About This 510(k) Submission

K013613 is an FDA 510(k) clearance for the SOFT PLUG ABSORBABLE PLUG-SA, a Plug, Punctum, submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 27, 2002, 234 days after receiving the submission on November 5, 2001. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K013613 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2001
Decision Date June 27, 2002
Days to Decision 234 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LZU — Plug, Punctum
Device Class

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