Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K093469 |
Device Name |
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS |
Applicant |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47402 -0489
|
|
Applicant Contact |
SUSANNE GALIN |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47402 -0489
|
|
Correspondent Contact |
SUSANNE GALIN |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 11/06/2009 |
Decision Date | 01/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|