Cleared Traditional

CILCO ANTERIOR CHAMBER LENS

K771933 · California Intraocular Lens · Ophthalmic
Jan 1978
Decision
104d
Days
Class 3
Risk

About This 510(k) Submission

K771933 is an FDA 510(k) clearance for the CILCO ANTERIOR CHAMBER LENS, a Intraocular Lens (Class III — Premarket Approval, product code HQL), submitted by California Intraocular Lens (Mchenry, US). The FDA issued a Cleared decision on January 26, 1978, 104 days after receiving the submission on October 14, 1977. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3600.

Submission Details

510(k) Number K771933 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1977
Decision Date January 26, 1978
Days to Decision 104 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQL — Intraocular Lens
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 886.3600