Cleared Traditional

RELIANCE OPHTHALMIC SLIT LAMP R-083

K834060 · F. & F. Koenigkramer · Ophthalmic
Feb 1984
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K834060 is an FDA 510(k) clearance for the RELIANCE OPHTHALMIC SLIT LAMP R-083, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by F. & F. Koenigkramer (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 71 days after receiving the submission on November 25, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K834060 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1983
Decision Date February 04, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390