Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K925288 |
Device Name |
TRACHEOSTOMY KIT |
Applicant |
AJS MEDICAL CO., INC. |
300 DAVISSON RUN RD. |
SUITE 301 |
CLARKSBURG,
WV
26301
|
|
Applicant Contact |
JAMES D WEINSTEIN |
Correspondent |
AJS MEDICAL CO., INC. |
300 DAVISSON RUN RD. |
SUITE 301 |
CLARKSBURG,
WV
26301
|
|
Correspondent Contact |
JAMES D WEINSTEIN |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 10/21/1992 |
Decision Date | 08/27/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|