Device Classification Name |
Device, Paste-On For Incontinence, Sterile
|
510(k) Number |
K915246 |
Device Name |
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) |
Applicant |
COLOPLAST A/S |
C/O RICHARD HAMER ASSOC., INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Applicant Contact |
RICHARD A HAMER |
Correspondent |
COLOPLAST A/S |
C/O RICHARD HAMER ASSOC., INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Correspondent Contact |
RICHARD A HAMER |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 11/15/1991 |
Decision Date | 02/05/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|