Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K904411 |
Device Name |
INTRASITE GEL (LABELING REVISION) |
Applicant |
SMITH & NEPHEW UNITED, INC. |
11775 STARKLEY RD. |
P.O.BOX 1970 |
LARGO,
FL
34649 -1970
|
|
Applicant Contact |
JIM IRVINE |
Correspondent |
SMITH & NEPHEW UNITED, INC. |
11775 STARKLEY RD. |
P.O.BOX 1970 |
LARGO,
FL
34649 -1970
|
|
Correspondent Contact |
JIM IRVINE |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 09/26/1990 |
Decision Date | 11/26/1990 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|