| Device Classification Name |
Bath, Sitz, Nonpowered
|
| 510(k) Number |
K851309 |
| Device Name |
ABCO PLASTIC UTENSILS |
| Applicant |
| Abco Dealers, Inc. |
| P.O. Box 17587 |
| 6637 N. Sidney Place |
|
Milwaukee,
WI
53217
|
|
| Applicant Contact |
CHRISTINE MEMETH |
| Correspondent |
| Abco Dealers, Inc. |
| P.O. Box 17587 |
| 6637 N. Sidney Place |
|
Milwaukee,
WI
53217
|
|
| Correspondent Contact |
CHRISTINE MEMETH |
| Regulation Number | 890.5125 |
| Classification Product Code |
|
| Date Received | 04/02/1985 |
| Decision Date | 07/01/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|