| Device Classification Name |
Container, Sharps
|
| 510(k) Number |
K872313 |
| Device Name |
NEEDLE & BLADE COUNTER & DISPOSAL UNIT |
| Applicant |
| Gary Plastic Packaging Corp. |
| 770 Garrison Ave. |
|
Bronx,
NY
10474
|
|
| Applicant Contact |
LISA HELLINGER |
| Correspondent |
| Gary Plastic Packaging Corp. |
| 770 Garrison Ave. |
|
Bronx,
NY
10474
|
|
| Correspondent Contact |
LISA HELLINGER |
| Regulation Number | 880.5570 |
| Classification Product Code |
|
| Date Received | 06/17/1987 |
| Decision Date | 07/02/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|