| 510(k) Number |
K853315 |
| Device Name |
CAUTERY TIP CLEANING PAD |
| Applicant |
| Kleen Test Products |
| 4425 W. Woolworth Ave. |
| P.O.B Ox 574 |
|
Milwaukee,
WI
53218
|
|
| Applicant Contact |
RICK W POENITSCH |
| Correspondent |
| Kleen Test Products |
| 4425 W. Woolworth Ave. |
| P.O.B Ox 574 |
|
Milwaukee,
WI
53218
|
|
| Correspondent Contact |
RICK W POENITSCH |
| Date Received | 08/07/1985 |
| Decision Date | 08/21/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|