Device Classification Name |
Dilator, Esophageal
|
510(k) Number |
K031147 |
Device Name |
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR |
Applicant |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
KIMBERLY SHOEMAKER |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
KIMBERLY SHOEMAKER |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 04/10/2003 |
Decision Date | 01/12/2004 |
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
|
|
|