POLYBONE— 510(k) K070012

Substantially Equivalent

Kyung Won Medical Co., Ltd.

FDA 510(k) clearance K070012 for POLYBONE, Substantially Equivalent on 2007-12-27. Applicant: Kyung Won Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kyung Won Medical Co., Ltd.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2007-01-03
Decision date: 2007-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, 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.