Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K052743 |
Device Name |
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 |
Applicant |
DYNAREX CORP. |
10 GLENSHAW ST. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
JAMES HURLMAN |
Correspondent |
DYNAREX CORP. |
10 GLENSHAW ST. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
JAMES HURLMAN |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 09/30/2005 |
Decision Date | 12/22/2005 |
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
|
|
|