| Device Classification Name |
Surgeon'S Gloves
|
| 510(k) Number |
K883736 |
| Device Name |
STERILE SURGEONS GLOVES |
| Applicant |
| Medical Manufacturers Marketing Co. |
| 15689 Chemical Ln. |
|
Huntington Beach,
CA
92649
|
|
| Applicant Contact |
RONALD R PATTERSON |
| Correspondent |
| Medical Manufacturers Marketing Co. |
| 15689 Chemical Ln. |
|
Huntington Beach,
CA
92649
|
|
| Correspondent Contact |
RONALD R PATTERSON |
| Regulation Number | 878.4460 |
| Classification Product Code |
|
| Date Received | 09/01/1988 |
| Decision Date | 10/12/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|