Cleared Traditional

CRISTY/COTE

K843096 · Titmus Optical, Inc. · Ophthalmic

Nov 1984

Decision

106d

Days

Class 1

Risk

About This 510(k) Submission

K843096 is an FDA 510(k) clearance for the CRISTY/COTE, a Lens, Spectacle, Non-custom (prescription) (Class I — General Controls, product code HQG), submitted by Titmus Optical, Inc. (Petersburg, US). The FDA issued a Cleared decision on November 21, 1984, 106 days after receiving the submission on August 7, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5844.

Submission Details

510(k) Number	K843096 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 1984
Decision Date	November 21, 1984
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—