| Device Classification Name |
Container, Sharps
|
| 510(k) Number |
K140285 |
| Device Name |
B TRAVELSAVVY SHARPS CONTAINER |
| Applicant |
| Bellegrove Medical Supply, Inc. |
| 8349 154th Ave. NE |
|
Redmond,
WA
98052
|
|
| Applicant Contact |
WAYNE MORSE |
| Correspondent |
| Bellegrove Medical Supply, Inc. |
| 8349 154th Ave. NE |
|
Redmond,
WA
98052
|
|
| Correspondent Contact |
WAYNE MORSE |
| Regulation Number | 880.5570 |
| Classification Product Code |
|
| Date Received | 02/04/2014 |
| Decision Date | 12/04/2014 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|