Device Classification Name |
tube, tracheal/bronchial, differential ventilation (w/wo connector)
|
510(k) Number |
K092886 |
Device Name |
WELL LEAD ENDOBRONCHIAL TUBES |
Applicant |
WELL LEAD INSTRUMENTS |
962 ALLEGRO LANE |
APOLLO BEACH,
FL
33570
|
|
Applicant Contact |
ARTHUR WARD |
Correspondent |
WELL LEAD INSTRUMENTS |
962 ALLEGRO LANE |
APOLLO BEACH,
FL
33570
|
|
Correspondent Contact |
ARTHUR WARD |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 09/21/2009 |
Decision Date | 03/11/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|