Cleared Traditional

HANSON MEDICAL GLUTEAL IMPLANT

K030809 · Hanson Medical, Inc. · General & Plastic Surgery
Apr 2003
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K030809 is an FDA 510(k) clearance for the HANSON MEDICAL GLUTEAL IMPLANT, a Elastomer, Silicone Block (Class II — Special Controls, product code MIB), submitted by Hanson Medical, Inc. (Goleta, US). The FDA issued a Cleared decision on April 21, 2003, 39 days after receiving the submission on March 13, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K030809 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2003
Decision Date April 21, 2003
Days to Decision 39 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MIB — Elastomer, Silicone Block
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620

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