Cleared Traditional

K945906 - SILICONE PUNCTAL PLUG (FDA 510(k) Clearance)

K945906 · Oasis Medical, Inc. · Ophthalmic device

Jan 1995

Decision

32d

Days

Risk

K945906 is an FDA 510(k) clearance for the SILICONE PUNCTAL PLUG. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number	K945906 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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	-