Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K840950 |
Device Name |
ZINC OXIDE TAPE |
Applicant |
GAINOR MEDICAL |
12520 YELLOWHEAD TRAIL |
|
|
Applicant Contact |
MARK GAINOR |
Correspondent |
GAINOR MEDICAL |
12520 YELLOWHEAD TRAIL |
|
|
Correspondent Contact |
MARK GAINOR |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 03/05/1984 |
Decision Date | 10/31/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|