Cleared Traditional

THORTON TITANIUM HOOK ANGLED RIGHT

K863988 · Keeler Instruments, Inc. · Ophthalmic
Oct 1986
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K863988 is an FDA 510(k) clearance for the THORTON TITANIUM HOOK ANGLED RIGHT, a Hook, Ophthalmic (Class I — General Controls, product code HNQ), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on October 31, 1986, 17 days after receiving the submission on October 14, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K863988 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1986
Decision Date October 31, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNQ — Hook, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350