SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM— 510(k) K112644

Name: FDA 510(k) clearance K112644
Creator: U.S. Food and Drug Administration
Published: 2012-12-19

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.. Device class: 2.

Clearance details

Applicant: Lotus Bio, Ltd.
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
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 ↗

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