Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K973911 |
Device Name |
2 GALLON ALTERNATE CARE SHARPS CONTAINER |
Applicant |
SAGE PRODUCTS, INC. |
815 TEK DR. |
CRYSTAL LAKE,
IL
60014 -8172
|
|
Applicant Contact |
KAREN PINTO |
Correspondent |
SAGE PRODUCTS, INC. |
815 TEK DR. |
CRYSTAL LAKE,
IL
60014 -8172
|
|
Correspondent Contact |
KAREN PINTO |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 10/14/1997 |
Decision Date | 10/29/1997 |
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
|
|
|