BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES— 510(k) K092554

Name: FDA 510(k) clearance K092554
Creator: U.S. Food and Drug Administration
Published: 2010-04-30

Substantially Equivalent

Sunlight Medical, Inc.

FDA 510(k) clearance K092554 for BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES, Substantially Equivalent on 2010-04-30. Applicant: Sunlight Medical, Inc.. Device class: 2.

Clearance details

Applicant: Sunlight Medical, Inc.
Product code: Code MQH
Device class: Class 2
Regulation: 21 CFR 884.6130
Advisory panel: Obstetrics/Gynecology
Date received: 2009-08-20
Decision date: 2010-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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