Cleared Special

OCU-GUARD AND OCU-GUARD SUPPLE

K983581 · Bio-Vascular, Inc. · Ophthalmic
Nov 1998
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K983581 is an FDA 510(k) clearance for the OCU-GUARD AND OCU-GUARD SUPPLE, a Implant, Orbital, Extra-ocular (Class II — Special Controls, product code HQX), submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 6, 1998, 24 days after receiving the submission on October 13, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3340.

Submission Details

510(k) Number K983581 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1998
Decision Date November 06, 1998
Days to Decision 24 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQX — Implant, Orbital, Extra-ocular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3340

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