Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K051019 |
Device Name |
SAFETY NEEDLE |
Applicant |
SARSTEDT, INC. |
1025 ST. JAMES CHURCH RD. |
NEWTON,
NC
28658
|
|
Applicant Contact |
PETER RUMSWINKEL |
Correspondent |
SARSTEDT, INC. |
1025 ST. JAMES CHURCH RD. |
NEWTON,
NC
28658
|
|
Correspondent Contact |
PETER RUMSWINKEL |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 04/22/2005 |
Decision Date | 07/25/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|