FDA.reportPublic FDA data

510(k) K014160

Device
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
Applicant
Cook Urological, Inc.
510(k) number
K014160
Product code
MQG
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-08
Date received
2001-12-19
Regulation
884.6120
Classification name
Accessory, Assisted Reproduction
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DEBBIE SCHMITT
Address
1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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