HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR

Arthroscope

GALLINI MEDICAL DEVICES, SRL

The following data is part of a premarket notification filed by Gallini Medical Devices, Srl with the FDA for Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - Lumbar.

Pre-market Notification Details

Device IDK141557
510k NumberK141557
Device Name:HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
ClassificationArthroscope
Applicant GALLINI MEDICAL DEVICES, SRL 1531 FELTON ROAD South Euclid,  OH  44121
ContactArthur S Goddard
CorrespondentArthur S Goddard
GALLINI MEDICAL DEVICES, SRL 1531 FELTON ROAD South Euclid,  OH  44121
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-12
Decision Date2014-12-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033737113844 K141557 000

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