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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K173110
Device Name GRAFTSITE
Applicant
Summit Medical Ltd.
Bourton Industrial Park
Bourton on the Water,  GB gl54 2hq
Applicant Contact Robyn Cochrane
Correspondent
Summit Medical Ltd.
Bourton Industrial Park
Bourton on the Water,  GB gl54 2hq
Correspondent Contact Robyn Cochrane
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
CAZ  
Date Received09/29/2017
Decision Date 05/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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