Device Classification Name |
Mask, Gas, Anesthetic
|
510(k) Number |
K874746 |
Device Name |
SEALFLEX MASK |
Applicant |
ENGINEERED MEDICAL SYSTEMS |
P.O. BOX 40543 |
INDIANAPOLIS,
IN
46240
|
|
Applicant Contact |
JEFF QUINN |
Correspondent |
ENGINEERED MEDICAL SYSTEMS |
P.O. BOX 40543 |
INDIANAPOLIS,
IN
46240
|
|
Correspondent Contact |
JEFF QUINN |
Regulation Number | 868.5550
|
Classification Product Code |
|
Date Received | 11/18/1987 |
Decision Date | 12/21/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|