Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K931611 |
Device Name |
PERCUTANEOUS TRACHEOSTOMY TUBE KIT |
Applicant |
CRANDALL MEDICAL DEVICES |
3129 YUKON AVE. |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
NORMAN CRANDALL |
Correspondent |
CRANDALL MEDICAL DEVICES |
3129 YUKON AVE. |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
NORMAN CRANDALL |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 04/01/1993 |
Decision Date | 08/27/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|