Device Classification Name |
stimulator, nerve, peripheral, electric
|
510(k) Number |
K023342 |
Device Name |
NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG |
Applicant |
HDC CORP. |
628 GIBRALTAR COURT |
MILPITAS,
CA
95035
|
|
Applicant Contact |
EARL SMART |
Correspondent |
HDC CORP. |
628 GIBRALTAR COURT |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
EARL SMART |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 10/07/2002 |
Decision Date | 03/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|