SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM— 510(k) K112644

Substantially Equivalent

Lotus Bio, Ltd.

FDA 510(k) clearance K112644 for SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM, Substantially Equivalent on 2012-12-19. Applicant: Lotus Bio, Ltd..

Clearance details

Applicant: Lotus Bio, Ltd.
Product code: Code MQK
Advisory panel: Obstetrics/Gynecology
Date received: 2011-09-12
Decision date: 2012-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pawtucket, RI, US

Download summary PDF View on FDA.gov ↗

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