Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K970018 |
Device Name |
FAST TRACT TRANSTRACHEAL PROCEDURE KIT |
Applicant |
L.W. WARD AND ASSOC., INC. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Applicant Contact |
LEWIS W WARD |
Correspondent |
L.W. WARD AND ASSOC., INC. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LEWIS W WARD |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 01/02/1997 |
Decision Date | 03/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|