Cleared Traditional

BONN MICRO IRIS HOOK (NON-STERILE) #7613

K801469 · Edward Weck, Inc. · Ophthalmic
Jul 1980
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K801469 is an FDA 510(k) clearance for the BONN MICRO IRIS HOOK (NON-STERILE) #7613, a Hook, Ophthalmic (Class I — General Controls, product code HNQ), submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 34 days after receiving the submission on June 24, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K801469 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1980
Decision Date July 28, 1980
Days to Decision 34 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