SATURN ACTIVE LASER SYSTEM

System, Assisted Reproduction Laser

RESEARCH INSTRUMENTS LTD.

The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Saturn Active Laser System.

Pre-market Notification Details

Device IDK083208
510k NumberK083208
Device Name:SATURN ACTIVE LASER SYSTEM
ClassificationSystem, Assisted Reproduction Laser
Applicant RESEARCH INSTRUMENTS LTD. BICKLAND INDUSTRIAL PARK Falmouth, Cornwall,  GB Tr11 4ta
Product CodeMRX  
CFR Regulation Number884.6200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-31
Decision Date2009-08-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.