Device Classification Name |
Catheter, Straight
|
510(k) Number |
K973070 |
Device Name |
CONVEEN EASICATH SET |
Applicant |
COLOPLAST CORP. |
1955 WEST OAK CIR. |
MARIETTA,
GA
30062 -2249
|
|
Applicant Contact |
SYDNEY LILLY |
Correspondent |
COLOPLAST CORP. |
1955 WEST OAK CIR. |
MARIETTA,
GA
30062 -2249
|
|
Correspondent Contact |
SYDNEY LILLY |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/18/1997 |
Decision Date | 11/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|