MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS— 510(k) K013964

Name: FDA 510(k) clearance K013964
Creator: U.S. Food and Drug Administration
Published: 2002-01-24

Substantially Equivalent

Cp Medical

FDA 510(k) clearance K013964 for MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS, Substantially Equivalent on 2002-01-24. 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: 2001-12-03
Decision date: 2002-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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