Device Classification Name |
syringe, antistick
|
510(k) Number |
K043419 |
Device Name |
P&P SAFETY SYRINGE |
Applicant |
MEDEXEL MEDICAL MFG. CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
MEDEXEL MEDICAL MFG. CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 12/13/2004 |
Decision Date | 04/15/2005 |
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
|
|
|