Cleared Traditional

RK VACUUM FIXATION RING SYSTEM

K863775 · Ameritek, Inc. · Ophthalmic
Oct 1986
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K863775 is an FDA 510(k) clearance for the RK VACUUM FIXATION RING SYSTEM, a Ring, Ophthalmic (flieringa) (Class I — General Controls, product code HNH), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on October 20, 1986, 24 days after receiving the submission on September 26, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K863775 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1986
Decision Date October 20, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNH — Ring, Ophthalmic (flieringa)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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