Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K963732 |
Device Name |
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA |
Applicant |
MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. |
P.O. BOX 5840 |
ST. LOUIS,
MO
63134
|
|
Applicant Contact |
MICHAEL B SCHOECK |
Correspondent |
MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. |
P.O. BOX 5840 |
ST. LOUIS,
MO
63134
|
|
Correspondent Contact |
MICHAEL B SCHOECK |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 09/17/1996 |
Decision Date | 06/26/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|