Device Classification Name |
Tape And Bandage, Adhesive
|
510(k) Number |
K852408 |
Device Name |
EXTRA LARGE ADHESIVE STRIPS |
Applicant |
AMERICAN WHITE CROSS, INC. |
56 WESTCOTT RD. |
STAMFORD,
CT
06902
|
|
Applicant Contact |
CORNELIA DAMSKY |
Correspondent |
AMERICAN WHITE CROSS, INC. |
56 WESTCOTT RD. |
STAMFORD,
CT
06902
|
|
Correspondent Contact |
CORNELIA DAMSKY |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 06/06/1985 |
Decision Date | 07/29/1985 |
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
|
|
|