Device Classification Name |
Strip, Adhesive, Closure, Skin
|
510(k) Number |
K831438 |
Device Name |
ELASTOPLAST |
Applicant |
BEIERSDORF, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BEIERSDORF, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 05/05/1983 |
Decision Date | 11/25/1983 |
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
|
|
|