FDA.report

510(k) K991379

Device
QUINN'S SPERM WASHING MEDIUM
Applicant
ADVANCED REPRODUCTIVE TECHNOLOGIES
510(k) number
K991379
Product code
MQL  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-02
Date received
1999-04-21
Regulation
884.6180
Classification name
Media, Reproductive
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
GREG HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

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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