Cleared Traditional

MEND APC

K924094 · Mend Technologies, Inc. · General & Plastic Surgery

Mar 1993

Decision

229d

Days

Class 1

Risk

About This 510(k) Submission

K924094 is an FDA 510(k) clearance for the MEND APC, a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I — General Controls, product code JEA), submitted by Mend Technologies, Inc. (Dallas, US). The FDA issued a Cleared decision on March 30, 1993, 229 days after receiving the submission on August 13, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K924094 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 1992
Decision Date	March 30, 1993
Days to Decision	229 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement