Device Classification Name |
dilator, esophageal
|
510(k) Number |
K043605 |
Device Name |
INSCOPE 3-STAGE BALLOON DILATOR |
Applicant |
CORDIS EUROPA, N.V. |
OOSTEINDE 8 |
RODEN,
NL
NL-9301 LJ
|
|
Applicant Contact |
HARM HOVINGA |
Correspondent |
CORDIS EUROPA, N.V. |
OOSTEINDE 8 |
RODEN,
NL
NL-9301 LJ
|
|
Correspondent Contact |
HARM HOVINGA |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 12/30/2004 |
Decision Date | 02/04/2005 |
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
|
|
|