LumenR Tissue Retractor System— 510(k) K153698

Substantially Equivalent

Lumenr, LLC

FDA 510(k) clearance K153698 for LumenR Tissue Retractor System, Substantially Equivalent on 2016-04-19. Applicant: Lumenr, LLC.

Clearance details

Applicant: Lumenr, LLC
Product code: Code ODB
Advisory panel: Gastroenterology, Urology
Date received: 2015-12-23
Decision date: 2016-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Matawan, NJ, US

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