Cleared Traditional

ILLUMINATED SPECULUM

K801058 · Designs For Vision, Inc. · General & Plastic Surgery
May 1980
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K801058 is an FDA 510(k) clearance for the ILLUMINATED SPECULUM, a Speculum, Illuminated (Class I — General Controls, product code FXF), submitted by Designs For Vision, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980, 22 days after receiving the submission on May 6, 1980. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.1800.

Submission Details

510(k) Number K801058 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1980
Decision Date May 28, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FXF — Speculum, Illuminated
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.1800