5mm Laparoscopic Electrode With J Hook, 5mm Laparoscopic Electrode With L Hook, 5mm Laparoscopic Electrode With Spatula, Monopolar Cable With 4mm Pin, Monopolar Cable With 8mm Pin

Electrosurgical, Cutting & Coagulation & Accessories

Purple Surgical International Limited

The following data is part of a premarket notification filed by Purple Surgical International Limited with the FDA for 5mm Laparoscopic Electrode With J Hook, 5mm Laparoscopic Electrode With L Hook, 5mm Laparoscopic Electrode With Spatula, Monopolar Cable With 4mm Pin, Monopolar Cable With 8mm Pin.

Pre-market Notification Details

Device IDK142868
510k NumberK142868
Device Name:5mm Laparoscopic Electrode With J Hook, 5mm Laparoscopic Electrode With L Hook, 5mm Laparoscopic Electrode With Spatula, Monopolar Cable With 4mm Pin, Monopolar Cable With 8mm Pin
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Purple Surgical International Limited 2 Chestnut House, Farm Close, Shenley,  GB Wd7 9ad
ContactJason Howes
CorrespondentAlan Schwartz
MDI CONSULTANTS, INC 55 NORTHERN BLVD., STE 200 Great Neck,  NY  11021
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-01
Decision Date2014-11-21
Summary:summary

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