| Device Classification Name |
Dressing, Wound, Occlusive
|
| 510(k) Number |
K881426 |
| Device Name |
PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE |
| Applicant |
| Laboratoire Pan-Pra |
| 2125, Boul. Industriel |
| Chambly, Que. |
|
Canada,
CA
J3L 4C5
|
|
| Applicant Contact |
DENIS BERTRAND |
| Correspondent |
| Laboratoire Pan-Pra |
| 2125, Boul. Industriel |
| Chambly, Que. |
|
Canada,
CA
J3L 4C5
|
|
| Correspondent Contact |
DENIS BERTRAND |
| Regulation Number | 878.4020 |
| Classification Product Code |
|
| Date Received | 04/05/1988 |
| Decision Date | 11/10/1988 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|