Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K935842 |
Device Name |
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE |
Applicant |
RUSCH, INC. |
2450 MEADOWBROOK PKWY. |
DULUTH,
GA
30096
|
|
Applicant Contact |
KARENANN J BROZOWSKI |
Correspondent |
RUSCH, INC. |
2450 MEADOWBROOK PKWY. |
DULUTH,
GA
30096
|
|
Correspondent Contact |
KARENANN J BROZOWSKI |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 12/07/1993 |
Decision Date | 05/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|