SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL— 510(k) K021311

Name: FDA 510(k) clearance K021311
Creator: U.S. Food and Drug Administration
Published: 2002-07-13

Substantially Equivalent

Cp Medical

FDA 510(k) clearance K021311 for SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL, Substantially Equivalent on 2002-07-13. Applicant: Cp Medical. Device class: 2.

Clearance details

Applicant: Cp Medical
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2002-04-25
Decision date: 2002-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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