Device Classification Name |
mask, gas, anesthetic
|
510(k) Number |
K953295 |
Device Name |
ANESTHESIA FACE MASK |
Applicant |
MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. |
P.O. BOX 5840 |
ST. LOUIS,
MO
63134
|
|
Applicant Contact |
ROBERT A VIRAG |
Correspondent |
MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. |
P.O. BOX 5840 |
ST. LOUIS,
MO
63134
|
|
Correspondent Contact |
ROBERT A VIRAG |
Regulation Number | 868.5550
|
Classification Product Code |
|
Date Received | 07/14/1995 |
Decision Date | 08/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|