Cleared Traditional

K873934 - RANGE OF CROCODILE ACTION INSTRUMENTS
(FDA 510(k) Clearance)

K873934 · Downs Surgical , Ltd. · Neurology

Dec 1987

Decision

83d

Days

Class 1

Risk

K873934 is an FDA 510(k) clearance for the RANGE OF CROCODILE ACTION INSTRUMENTS. This device is classified as a Instrument, Microsurgical (Class I — General Controls, product code GZX).

Submitted by Downs Surgical , Ltd. (Sheffield S9 4wj, GB). The FDA issued a Cleared decision on December 17, 1987, 83 days after receiving the submission on September 25, 1987.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4525.

Submission Details

510(k) Number	K873934 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 1987
Decision Date	December 17, 1987
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—