| Device Classification Name |
Tape And Bandage, Adhesive
|
| 510(k) Number |
K880207 |
| Device Name |
EXPANDOVER ELASTIC BANDAGE |
| Applicant |
| EXPANDOVER C/O HALE AND DORR |
| 60 STATE ST. |
|
BOSTON,
MA
02109
|
|
| Applicant Contact |
JOHN H MORTON |
| Correspondent |
| EXPANDOVER C/O HALE AND DORR |
| 60 STATE ST. |
|
BOSTON,
MA
02109
|
|
| Correspondent Contact |
JOHN H MORTON |
| Regulation Number | 880.5240 |
| Classification Product Code |
|
| Date Received | 01/15/1988 |
| Decision Date | 04/21/1988 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 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
|