Cleared Traditional

K852402 - NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
(FDA 510(k) Clearance)

K852402 · North American Instrument Corp. · General & Plastic Surgery device

Jul 1985

Decision

35d

Days

Class 1

Risk

K852402 is an FDA 510(k) clearance for the NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER. This device is classified as a Guide, Surgical, Instrument (Class I - General Controls, product code FZX).

Submitted by North American Instrument Corp. (Hudson Falls, US). The FDA issued a Cleared decision on July 11, 1985, 35 days after receiving the submission on June 6, 1985.

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

Submission Details

510(k) Number	K852402 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 1985
Decision Date	July 11, 1985
Days to Decision	35 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—