Device Classification Name |
Clamp, Penile
|
510(k) Number |
K954959 |
Device Name |
CAP-AID |
Applicant |
NEBL, INC. |
44 TERRACE DR. |
WORCHESTER,
MA
01609
|
|
Applicant Contact |
JEFFREY A DANN |
Correspondent |
NEBL, INC. |
44 TERRACE DR. |
WORCHESTER,
MA
01609
|
|
Correspondent Contact |
JEFFREY A DANN |
Regulation Number | 876.5160
|
Classification Product Code |
|
Date Received | 10/27/1995 |
Decision Date | 12/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|