Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K935777 |
Device Name |
SHARPSAFE, CAT. NO. 4125 |
Applicant |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. |
KEENE,
NH
03431
|
|
Applicant Contact |
TIMOTHY J TALCOTT |
Correspondent |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. |
KEENE,
NH
03431
|
|
Correspondent Contact |
TIMOTHY J TALCOTT |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 12/03/1993 |
Decision Date | 02/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|