| Device Classification Name |
Container, Sharps
|
| 510(k) Number |
K884448 |
| Device Name |
BLADEMATE |
| Applicant |
| V.I.R. Engineering, Inc. |
| 5901 Encina Rd., Suite B-3 |
|
Goleta,
CA
93117
|
|
| Applicant Contact |
VINCENT, MA |
| Correspondent |
| V.I.R. Engineering, Inc. |
| 5901 Encina Rd., Suite B-3 |
|
Goleta,
CA
93117
|
|
| Correspondent Contact |
VINCENT, MA |
| Regulation Number | 880.5570 |
| Classification Product Code |
|
| Date Received | 10/21/1988 |
| Decision Date | 11/17/1988 |
| 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
|
|
|