SATURN 3 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 3 Laser System.

Pre-market Notification Details

Device IDK060764
510k NumberK060764
Device Name:SATURN 3 LASER SYSTEM
ClassificationSystem, Assisted Reproduction Laser
Applicant RESEARCH INSTRUMENTS LTD. 3722 AVE. SAUSALITO Irvine,  CA  92606
ContactGrace Holland
CorrespondentGrace Holland
RESEARCH INSTRUMENTS LTD. 3722 AVE. SAUSALITO Irvine,  CA  92606
Product CodeMRX  
CFR Regulation Number884.6200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-21
Decision Date2007-03-12
Summary:summary

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