Device Classification Name |
syringe, piston
|
510(k) Number |
K972878 |
Device Name |
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 |
Applicant |
SAFETY SYRINGES, INC. |
250 W. COLORADO BLVD. |
SUITE 101 |
ARCADIA,
CA
91007
|
|
Applicant Contact |
ANTHONY PEREZ |
Correspondent |
SAFETY SYRINGES, INC. |
250 W. COLORADO BLVD. |
SUITE 101 |
ARCADIA,
CA
91007
|
|
Correspondent Contact |
ANTHONY PEREZ |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 08/04/1997 |
Decision Date | 10/30/1997 |
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
|
|
|