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 |
Spectra Medical Devices, Inc |
299 Ballardvale St., Suite I, |
Wilmington,
MA
01887
|
|
Correspondent Contact |
Kathy Dassler |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 04/21/2015 |
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
|
|
|