LOGIC LAPAROSCOPIC SCISSORS

Electrosurgical, Cutting & Coagulation & Accessories

SURGICAL INNOVATIONS PLC

The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Logic Laparoscopic Scissors.

Pre-market Notification Details

Device IDK063485
510k NumberK063485
Device Name:LOGIC LAPAROSCOPIC SCISSORS
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant SURGICAL INNOVATIONS PLC CLAYTON PARK CLAYTON WOOD RISE Leeds,  GB Ls16 6rf
ContactStuart Moran
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-11-17
Decision Date2006-12-01
Summary:summary

NIH GUDID Devices

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