Cleared Traditional

MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY

K854262 · Meadox Surgimed, Inc. · General & Plastic Surgery

Dec 1985

Decision

62d

Days

Class 1

Risk

About This 510(k) Submission

K854262 is an FDA 510(k) clearance for the MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY, a Guide, Surgical, Instrument (Class I — General Controls, product code FZX), submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on December 24, 1985, 62 days after receiving the submission on October 23, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K854262 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1985
Decision Date	December 24, 1985
Days to Decision	62 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—