Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K031453 |
Device Name |
TERUMO SURGUARD 2 SAFETY NEEDLE |
Applicant |
TERUMO MEDICAL CORP. |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Applicant Contact |
BARBARA SMITH |
Correspondent |
TERUMO MEDICAL CORP. |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Correspondent Contact |
BARBARA SMITH |
Regulation Number | 880.5570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/07/2003 |
Decision Date | 07/08/2003 |
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
|
|
|