Device Classification Name |
catheters, suction, tracheobronchial
|
510(k) Number |
K982945 |
Device Name |
DUAL PURPOSE CLOSED CATHETER |
Applicant |
SPIRIT MEDICAL SYSTEMS, INC. |
16267 WHITESTONE DR. |
PARKER,
CO
80134
|
|
Applicant Contact |
JEFF SAWYER |
Correspondent |
SPIRIT MEDICAL SYSTEMS, INC. |
16267 WHITESTONE DR. |
PARKER,
CO
80134
|
|
Correspondent Contact |
JEFF SAWYER |
Regulation Number | 868.6810
|
Classification Product Code |
|
Date Received | 08/21/1998 |
Decision Date | 09/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|