Device Classification Name |
syringe, antistick
|
510(k) Number |
K122558 |
Device Name |
ULTRASAFE PASSIVE NEEDLE GUARD |
Applicant |
SAFETY SYRINGES, INC. |
2875 Loker Ave E |
CARLSBAD,
CA
92010
|
|
Applicant Contact |
SUZANNE RICHARDSON |
Correspondent |
SAFETY SYRINGES, INC. |
2875 Loker Ave E |
CARLSBAD,
CA
92010
|
|
Correspondent Contact |
SUZANNE RICHARDSON |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 08/22/2012 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|