Cleared Traditional

STORZ ENT/OPHTHALMIC MAXI CHAIR

K870112 · Storz Instrument Co. · Ophthalmic
Feb 1987
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K870112 is an FDA 510(k) clearance for the STORZ ENT/OPHTHALMIC MAXI CHAIR, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 12, 1987, 31 days after receiving the submission on January 12, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number K870112 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1987
Decision Date February 12, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HME — Chair, Ophthalmic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1140

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