Cleared Traditional

ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR

K925641 · Carl Zeiss, Inc. · Ophthalmic
Sep 1993
Decision
304d
Days
Class 2
Risk

About This 510(k) Submission

K925641 is an FDA 510(k) clearance for the ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Carl Zeiss, Inc. (Princeton, US). The FDA issued a Cleared decision on September 9, 1993, 304 days after receiving the submission on November 9, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K925641 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1992
Decision Date September 09, 1993
Days to Decision 304 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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