FDA.report

510(k) K090652

Device
ALPHA DUO LAP INSUFFLATOR
Applicant
HIPPOKRATEC GMBH
510(k) number
K090652
Product code
HIF  
Decision
Substantially Equivalent (SESE)
Decision date
2009-09-25
Date received
2009-03-11
Regulation
884.1730
Classification name
Insufflator, Laparoscopic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
CHRISTIAN SIEDERSBERGER
Address
Am Windfeld 36 Miebach, Bavaria DE 83714 83714

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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