SILHOUETTE, MODEL 1000.01— 510(k) K070426

Name: FDA 510(k) clearance K070426
Creator: U.S. Food and Drug Administration
Published: 2007-06-29

Substantially Equivalent

Aranz Medical Limited

FDA 510(k) clearance K070426 for SILHOUETTE, MODEL 1000.01, Substantially Equivalent on 2007-06-29. Applicant: Aranz Medical Limited. Device class: 1.

Clearance details

Applicant: Aranz Medical Limited
Product code: Code FXN
Device class: Class 1
Regulation: 21 CFR 878.4160
Advisory panel: General, Plastic Surgery
Date received: 2007-02-13
Decision date: 2007-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Christchurch, Canterbury, NZ

Download summary PDF View on FDA.gov ↗

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