Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K922959 |
Device Name |
ISOPORE TAPE |
Applicant |
LECTEC CORP. |
10701 RED CIRCLE DR. |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
CHAD MILLER |
Correspondent |
LECTEC CORP. |
10701 RED CIRCLE DR. |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
CHAD MILLER |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 06/18/1992 |
Decision Date | 09/11/1992 |
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
|
|
|