DeviceClearance

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

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.

Clearance details

Applicant
Helix Medical, LLC
Product code
Code LFB
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carpinteria, CA, US
Download summary PDFView on FDA.gov ↗

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