Cleared Traditional

MONARCH NASAL IMPLANT

K071018 · Hanson Medical, Inc. · General & Plastic Surgery
May 2007
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K071018 is an FDA 510(k) clearance for the MONARCH NASAL IMPLANT, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Hanson Medical, Inc. (Kingston, US). The FDA issued a Cleared decision on May 25, 2007, 45 days after receiving the submission on April 10, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K071018 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2007
Decision Date May 25, 2007
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZE — Prosthesis, Nose, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3680

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