Cleared Traditional

ANVIL RETRACTOR

K830585 · Twin City Surgical, Inc. · General & Plastic Surgery
May 1983
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K830585 is an FDA 510(k) clearance for the ANVIL RETRACTOR, a Retractor (Class I — General Controls, product code GAD), submitted by Twin City Surgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983, 93 days after receiving the submission on February 23, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K830585 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 1983
Decision Date May 27, 1983
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GAD — Retractor
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800