Device Classification Name |
syringe, piston
|
510(k) Number |
K011951 |
Device Name |
EZ SYRINGE |
Applicant |
OWEN MUMFORD, LTD. |
1755 A WEST OAK COMMONS COURT |
MARIETTA,
GA
30062
|
|
Applicant Contact |
ROBERT SHAW |
Correspondent |
OWEN MUMFORD, LTD. |
1755 A WEST OAK COMMONS COURT |
MARIETTA,
GA
30062
|
|
Correspondent Contact |
ROBERT SHAW |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 06/21/2001 |
Decision Date | 08/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|