Device Classification Name |
Device, Paste-On For Incontinence, Sterile
|
510(k) Number |
K963950 |
Device Name |
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE |
Applicant |
BIODERM, INC. |
29 AINSWORTH AVE. |
EAST BRUNSWICK,
NJ
08816
|
|
Applicant Contact |
ERIC FLAM |
Correspondent |
BIODERM, INC. |
29 AINSWORTH AVE. |
EAST BRUNSWICK,
NJ
08816
|
|
Correspondent Contact |
ERIC FLAM |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 10/02/1996 |
Decision Date | 01/10/1997 |
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
|
|
|