| Device Classification Name |
Dressing, Wound And Burn, Occlusive
|
| 510(k) Number |
K960847 |
| Device Name |
DERMASEAL |
| Applicant |
| Bellingham Medical, Inc. |
| 2401 Pilot Knob Rd., Suite 118 |
|
Mendota Heights,
MN
55120
|
|
| Applicant Contact |
JULIA LORD |
| Correspondent |
| Bellingham Medical, Inc. |
| 2401 Pilot Knob Rd., Suite 118 |
|
Mendota Heights,
MN
55120
|
|
| Correspondent Contact |
JULIA LORD |
| Classification Product Code |
|
| Date Received | 02/21/1996 |
| Decision Date | 04/04/1996 |
| 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
|
|
|