Cleared Traditional

K915175 - REDDICK RETRACTOR
(FDA 510(k) Clearance)

K915175 · Ideal Medical, Inc. · General & Plastic Surgery

Apr 1992

Decision

166d

Days

Class 1

Risk

K915175 is an FDA 510(k) clearance for the REDDICK RETRACTOR. This device is classified as a Retractor (Class I — General Controls, product code GAD).

Submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 29, 1992, 166 days after receiving the submission on November 15, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K915175 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 15, 1991
Decision Date	April 29, 1992
Days to Decision	166 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement