MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,— 510(k) K033903

Name: FDA 510(k) clearance K033903
Creator: U.S. Food and Drug Administration
Published: 2004-01-16

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K033903 for MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,, Substantially Equivalent on 2004-01-16. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code MQH
Device class: Class 2
Regulation: 21 CFR 884.6130
Advisory panel: Obstetrics/Gynecology
Date received: 2003-12-17
Decision date: 2004-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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