BLASTFREEZE AND BLASTTHAW— 510(k) K031486

Substantially Equivalent

Medicult A/S

FDA 510(k) clearance K031486 for BLASTFREEZE AND BLASTTHAW, Substantially Equivalent on 2003-06-27. Applicant: Medicult A/S. Device class: 2.

Clearance details

Applicant: Medicult A/S
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2003-05-12
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medicult A/S

K080172 — BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 12162008-12-18
K081639 — ICSI CUMULASE2008-09-19
K080473 — EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED2008-09-03
K061309 — EMBRYOASSIST2007-02-08
K061145 — SPERMSLOW2006-10-02

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