SERI Contour— 510(k) K172545

Substantially Equivalent

Sofregen Medical, Inc.

FDA 510(k) clearance K172545 for SERI Contour, Substantially Equivalent on 2017-09-22. Applicant: Sofregen Medical, Inc..

Clearance details

Applicant: Sofregen Medical, Inc.
Product code: Code OXF
Advisory panel: General, Plastic Surgery
Date received: 2017-08-23
Decision date: 2017-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Medford, MA, US

Download summary PDF View on FDA.gov ↗

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