Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K021540 |
Device Name |
RUSCH EDGAR TUBE |
Applicant |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
RICK LYKINS |
Correspondent |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
RICK LYKINS |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 05/10/2002 |
Decision Date | 08/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|