BLOM-SINGER SEPTAL PERFORATION PROSTHESIS— 510(k) K131745

Name: FDA 510(k) clearance K131745
Creator: U.S. Food and Drug Administration
Published: 2013-09-17

Substantially Equivalent

Helix Medical, LLC

FDA 510(k) clearance K131745 for BLOM-SINGER SEPTAL PERFORATION PROSTHESIS, Substantially Equivalent on 2013-09-17. Applicant: Helix Medical, LLC. Device class: Unclassified.

Clearance details

Applicant: Helix Medical, LLC
Product code: Code LFB
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-06-13
Decision date: 2013-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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