Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K936224 |
Device Name |
REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS |
Applicant |
MALLINCKRODT MEDICAL TPI, INC. |
1595 DEERE AVE. |
P.O. BOX 19614 |
IRVINE,
CA
92714
|
|
Applicant Contact |
AMY BOUCLY |
Correspondent |
MALLINCKRODT MEDICAL TPI, INC. |
1595 DEERE AVE. |
P.O. BOX 19614 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
AMY BOUCLY |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 12/07/1993 |
Decision Date | 08/30/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|