Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K965248 |
Device Name |
BEMIS TWO GALLON SHARPS CONTAINER |
Applicant |
BEMIS MFG. CO. |
300 MILL ST. |
SHEBOYGAN FALLS,
WI
53085
|
|
Applicant Contact |
JOHN B HOWELL |
Correspondent |
BEMIS MFG. CO. |
300 MILL ST. |
SHEBOYGAN FALLS,
WI
53085
|
|
Correspondent Contact |
JOHN B HOWELL |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 12/04/1996 |
Decision Date | 02/14/1997 |
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
|
Recalls |
CDRH Recalls
|
|
|