Cleared Traditional

K061398 - SNUG PLUG PUNCTUM PLUG
(FDA 510(k) Clearance)

K061398 · Fci Ophthalmics, Inc. · Ophthalmic

Jul 2006

Decision

53d

Days

—

Risk

K061398 is an FDA 510(k) clearance for the SNUG PLUG PUNCTUM PLUG, a Plug, Punctum, submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on July 11, 2006, 53 days after receiving the submission on May 19, 2006. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K061398 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2006
Decision Date	July 11, 2006
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement