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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 K151069
Device Name SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
Applicant
SPECTRA MEDICAL DEVICES, INC.
260 F/H Fordham Road
WILMINGTON,  MA  01887
Applicant Contact Agustin Turriza
Correspondent
AJW Technology Consultants, Inc.
445 Apollo Beach Blvd
Apollo Beach,  FL  33572
Correspondent Contact Tanya O'Brien
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/21/2015
Decision Date 02/05/2016
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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