Device Classification Name |
Beads, Hydrophilic, For Wound Exudate Absorption
|
510(k) Number |
K904412 |
Device Name |
ALLEVYN DRESSING CLAIMS CHANGE |
Applicant |
SMITH & NEPHEW UNITED, INC. |
11775 STARKLEY RD. |
P.O.BOX 1970 |
LARGO,
FL
34649 -1970
|
|
Applicant Contact |
JIM IRVIN |
Correspondent |
SMITH & NEPHEW UNITED, INC. |
11775 STARKLEY RD. |
P.O.BOX 1970 |
LARGO,
FL
34649 -1970
|
|
Correspondent Contact |
JIM IRVIN |
Regulation Number | 878.4018
|
Classification Product Code |
|
Date Received | 09/26/1990 |
Decision Date | 10/23/1990 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|