Cleared Traditional

KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT

K801418 · Keeler Optical Products , Ltd. · Ophthalmic
Jul 1980
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K801418 is an FDA 510(k) clearance for the KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT, a Unit, Cryophthalmic (Class II — Special Controls, product code HPS), submitted by Keeler Optical Products , Ltd. (Walker, US). The FDA issued a Cleared decision on July 21, 1980, 34 days after receiving the submission on June 17, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K801418 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1980
Decision Date July 21, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPS — Unit, Cryophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4170