Cleared Traditional

K853376 - MORGAN SUTURE-DRILL
(FDA 510(k) Clearance)

K853376 · Bowen & Company, Inc. · Orthopedic

Nov 1985

Decision

93d

Days

Class 1

Risk

K853376 is an FDA 510(k) clearance for the MORGAN SUTURE-DRILL, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on November 13, 1985, 93 days after receiving the submission on August 12, 1985. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K853376 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1985
Decision Date	November 13, 1985
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820