Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K944451 |
Device Name |
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES) |
Applicant |
PASSY-MUIR, INC. |
4521 CAMPUS DRIVE, SUITE 273 |
IRVINE,
CA
92715
|
|
Applicant Contact |
PATRICIA E PASSY |
Correspondent |
PASSY-MUIR, INC. |
4521 CAMPUS DRIVE, SUITE 273 |
IRVINE,
CA
92715
|
|
Correspondent Contact |
PATRICIA E PASSY |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 09/12/1994 |
Decision Date | 07/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|