Cleared Traditional

MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.

K871195 · Military Engineering, Inc. · General & Plastic Surgery

Apr 1987

Decision

13d

Days

Class 1

Risk

About This 510(k) Submission

K871195 is an FDA 510(k) clearance for the MALLET, BONE SURGERY, STAINLESS STEEL, 2LB., a Mallet (Class I — General Controls, product code HXL), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 6, 1987, 13 days after receiving the submission on March 24, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K871195 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1987
Decision Date	April 06, 1987
Days to Decision	13 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—