Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K903823 |
Device Name |
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE |
Applicant |
SMITH AND NEPHEW DONJOY, INC. |
2777 LOKER AVENUE WEST |
CARSBAD,
CA
92008 -6601
|
|
Applicant Contact |
GREGORY R NELSON |
Correspondent |
SMITH AND NEPHEW DONJOY, INC. |
2777 LOKER AVENUE WEST |
CARSBAD,
CA
92008 -6601
|
|
Correspondent Contact |
GREGORY R NELSON |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 08/20/1990 |
Decision Date | 01/16/1991 |
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
|
|
|