FDA.report

510(k) K030525

Device
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
Applicant
MID-ATLANTIC DIAGNOSTICS, INC.
510(k) number
K030525
Product code
MQG  
Decision
Substantially Equivalent (SESE)
Decision date
2003-08-27
Date received
2003-02-19
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
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
SUSAN J BUSH
Address
438 N. Elmwood Rd. Marlton NJ US 08053 08053

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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