Cleared Traditional

VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}

K953394 · Visitec Co. · Ophthalmic
Oct 1995
Decision
87d
Days
—
Risk

About This 510(k) Submission

K953394 is an FDA 510(k) clearance for the VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}, a Plug, Punctum, submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on October 12, 1995, 87 days after receiving the submission on July 17, 1995. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K953394 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1995
Decision Date October 12, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LZU — Plug, Punctum
Device Class —

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