FDA.report

510(k) K991229

Device
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
Applicant
HENNING KNUDSEN ENGINEERING A/S
510(k) number
K991229
Product code
MQG  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-29
Date received
1999-04-12
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
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JACOB MOLLENBACH
Address
Klintehoj Vaenge 1 Birkerod DK DK-3460 DK-3460

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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