CRYOTIP— 510(k) K041562

Substantially Equivalent

Irvine Scientific Sales Co., Inc.

FDA 510(k) clearance K041562 for CRYOTIP, Substantially Equivalent on 2004-08-09. Applicant: Irvine Scientific Sales Co., Inc.. Device class: 2.

Clearance details

Applicant: Irvine Scientific Sales Co., Inc.
Product code: Code MQH
Device class: Class 2
Regulation: 21 CFR 884.6130
Advisory panel: Obstetrics/Gynecology
Date received: 2004-06-10
Decision date: 2004-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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