Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K972423 |
Device Name |
RUSCH TRACHEOFIX-SET |
Applicant |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
JAMES R WHITNEY |
Correspondent |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
JAMES R WHITNEY |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 06/27/1997 |
Decision Date | 02/13/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|