Cleared Traditional

HANSON MEDICAL FACIAL IMPLANTS

K090803 · Hanson Medical, Inc. · General & Plastic Surgery
Jun 2010
Decision
463d
Days
Class 2
Risk

About This 510(k) Submission

K090803 is an FDA 510(k) clearance for the HANSON MEDICAL FACIAL IMPLANTS, 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 June 30, 2010, 463 days after receiving the submission on March 24, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K090803 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2009
Decision Date June 30, 2010
Days to Decision 463 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

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