Cleared Traditional

K924784 - BURTON PROJECTOR HEAD - MODEL 6000-H
(FDA 510(k) Clearance)

Apr 1993
Decision
194d
Days
Class 1
Risk

K924784 is an FDA 510(k) clearance for the BURTON PROJECTOR HEAD - MODEL 6000-H. This device is classified as a Projector, Ophthalmic (Class I - General Controls, product code HOS).

Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 5, 1993, 194 days after receiving the submission on September 23, 1992.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1680.

Submission Details

510(k) Number K924784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date April 05, 1993
Days to Decision 194 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HOS — Projector, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1680

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