Device Classification Name |
Condenser, Heat And Moisture (Artificial Nose)
|
510(k) Number |
K942794 |
Device Name |
HYGROLIFE |
Applicant |
MALLINCKRODT MEDICAL |
R.D. #1 BOX 1173 |
HOOK ROAD |
ARGYLE,
NY
12809
|
|
Applicant Contact |
JAMES C WEBBER |
Correspondent |
MALLINCKRODT MEDICAL |
R.D. #1 BOX 1173 |
HOOK ROAD |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
JAMES C WEBBER |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 06/14/1994 |
Decision Date | 08/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|