Cleared Traditional

K853601 - MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
(FDA 510(k) Clearance)

K853601 · Bowen & Company, Inc. · General & Plastic Surgery
Sep 1985
Decision
20d
Days
Class 1
Risk

K853601 is an FDA 510(k) clearance for the MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP, a Rasp, Surgical, General & Plastic Surgery (Class I — General Controls, product code GAC), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on September 16, 1985, 20 days after receiving the submission on August 27, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K853601 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1985
Decision Date September 16, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GAC — Rasp, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800