Device Classification Name |
resuscitator, manual, non self-inflating
|
510(k) Number |
K001714 |
Device Name |
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 |
Applicant |
MERCURY MEDICAL |
11300 49TH ST. NORTH |
CLEARWATER,
FL
33762 -4800
|
|
Applicant Contact |
RON RUPENSKI |
Correspondent |
MERCURY MEDICAL |
11300 49TH ST. NORTH |
CLEARWATER,
FL
33762 -4800
|
|
Correspondent Contact |
RON RUPENSKI |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/05/2000 |
Decision Date | 11/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|