POWERFLEX PEC IMPLANT— 510(k) K973729

Substantially Equivalent

Hanson Medical, Inc.

FDA 510(k) clearance K973729 for POWERFLEX PEC IMPLANT, Substantially Equivalent on 1997-12-24. Applicant: Hanson Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hanson Medical, Inc.
Product code: Code MIC
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1997-09-30
Decision date: 1997-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.