GRAFTSITE

Needle, Conduction, Anesthetic (w/wo Introducer)

Summit Medical Ltd.

The following data is part of a premarket notification filed by Summit Medical Ltd. with the FDA for Graftsite.

Pre-market Notification Details

Device IDK173110
510k NumberK173110
Device Name:GRAFTSITE
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant Summit Medical Ltd. Bourton Industrial Park Bourton On The Water,  GB Gl54 2hq
ContactRobyn Cochrane
CorrespondentRobyn Cochrane
Summit Medical Ltd. Bourton Industrial Park Bourton On The Water,  GB Gl54 2hq
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-05-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15060238201145 K173110 000

Trademark Results [GRAFTSITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GRAFTSITE
GRAFTSITE
88292982 not registered Live/Pending
Summit Medical Limited
2019-02-07

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