SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM

Instrument, Ultrasonic Surgical

SRA DEVELOPMENTS, LTD.

The following data is part of a premarket notification filed by Sra Developments, Ltd. with the FDA for Series 3 Lotus Laparoscopic Ultrasound Surgery System.

Pre-market Notification Details

Device IDK063531
510k NumberK063531
Device Name:SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
ClassificationInstrument, Ultrasonic Surgical
Applicant SRA DEVELOPMENTS, LTD. BREMRIDGE HOUSE Ashburton, Devon,  GB Tq13 7jx
ContactMichael J.r. Young
CorrespondentMichael J.r. Young
SRA DEVELOPMENTS, LTD. BREMRIDGE HOUSE Ashburton, Devon,  GB Tq13 7jx
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-22
Decision Date2007-02-22
Summary:summary

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