Cleared Traditional

K781715 - RULER, WECK SCOTT
(FDA 510(k) Clearance)

Dec 1978
Decision
60d
Days
Class 1
Risk

K781715 is an FDA 510(k) clearance for the RULER, WECK SCOTT. This device is classified as a Caliper, Ophthalmic (Class I - General Controls, product code HOE).

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978, 60 days after receiving the submission on October 5, 1978.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K781715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1978
Decision Date December 04, 1978
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HOE — Caliper, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.4350