Cleared Traditional

K882349 - MALLET, SURGICAL
(FDA 510(k) Clearance)

K882349 · Treace Medical, Inc. · General & Plastic Surgery device

Jun 1988

Decision

16d

Days

Class 1

Risk

K882349 is an FDA 510(k) clearance for the MALLET, SURGICAL. This device is classified as a Mallet (Class I - General Controls, product code HXL).

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on June 23, 1988, 16 days after receiving the submission on June 7, 1988.

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

Submission Details

510(k) Number	K882349 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 07, 1988
Decision Date	June 23, 1988
Days to Decision	16 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—