Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K983519 |
Device Name |
COMFEEL SEASORB DRESSING |
Applicant |
COLOPLAST CORP. |
1955 WEST OAK CIR. |
MARIETTA,
GA
30062 -2249
|
|
Applicant Contact |
M.SYDNEY LILLY |
Correspondent |
COLOPLAST CORP. |
1955 WEST OAK CIR. |
MARIETTA,
GA
30062 -2249
|
|
Correspondent Contact |
M.SYDNEY LILLY |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 10/08/1998 |
Decision Date | 12/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|