Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K041153 |
Device Name |
SHARPSAWAY II LOCKING DISPOSABLE CUP |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
ELIZABETH PRICE |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
ELIZABETH PRICE |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 05/03/2004 |
Decision Date | 07/12/2004 |
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
|
|
|