Cleared Traditional

RELIANCE 1379

K853359 · Dentsply Intl. · Ophthalmic
Sep 1985
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K853359 is an FDA 510(k) clearance for the RELIANCE 1379, a Table, Instrument, Powered, Ophthalmic (Class I — General Controls, product code HRJ), submitted by Dentsply Intl. (Cincinnati, US). The FDA issued a Cleared decision on September 24, 1985, 43 days after receiving the submission on August 12, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4855.

Submission Details

510(k) Number K853359 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1985
Decision Date September 24, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HRJ — Table, Instrument, Powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4855

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