Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K961449 |
Device Name |
TRACHEOSTOMY TUBES TRACOE-FLEX |
Applicant |
TRACOE MEDICAL GMBH |
REICHSFORSTSTR. 32 |
FRANKFURT/M,
DE
D-60528
|
|
Applicant Contact |
FRANZ WALDECK, M.D., PH.D. |
Correspondent |
TRACOE MEDICAL GMBH |
REICHSFORSTSTR. 32 |
FRANKFURT/M,
DE
D-60528
|
|
Correspondent Contact |
FRANZ WALDECK, M.D., PH.D. |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 04/16/1996 |
Decision Date | 09/13/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|