Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K012736 |
Device Name |
MONOJECT SAFETY NEEDLE |
Applicant |
TYCO HEALTHCARE |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
DAVID A OLSON |
Correspondent |
TYCO HEALTHCARE |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
DAVID A OLSON |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 08/16/2001 |
Decision Date | 10/25/2001 |
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
|
Recalls |
CDRH Recalls
|
|
|