Cleared Traditional

S 22 INSTRUMENT STAND

K891584 · Carl Zeiss, Inc. · General & Plastic Surgery
Jun 1989
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K891584 is an FDA 510(k) clearance for the S 22 INSTRUMENT STAND, a Microscope, Operating & Accessories, Ac-powered, Ophthalmic (Class I — General Controls, product code HRM), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on June 8, 1989, 80 days after receiving the submission on March 20, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4700.

Submission Details

510(k) Number K891584 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1989
Decision Date June 08, 1989
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HRM — Microscope, Operating & Accessories, Ac-powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4700

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