| 510(k) Number |
K882388 |
| Device Name |
MR. RAZOR II TWIN |
| Applicant |
| Burney Products Corp. |
| 91 Ingraham St. |
|
Brooklyn,
NY
11237
|
|
| Applicant Contact |
HENRY J BURNEY |
| Correspondent |
| Burney Products Corp. |
| 91 Ingraham St. |
|
Brooklyn,
NY
11237
|
|
| Correspondent Contact |
HENRY J BURNEY |
| Classification Product Code |
|
| Date Received | 06/10/1988 |
| Decision Date | 07/13/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|