Device Classification Name |
endoscopic suture/plication system, gastroesophageal reflux disease (gerd)
|
510(k) Number |
K071553 |
Device Name |
ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR |
Applicant |
NDO SURGICAL, INC. |
125 HIGH ST., |
SUITE 7 |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
JOHN J VOZELLA |
Correspondent |
NDO SURGICAL, INC. |
125 HIGH ST., |
SUITE 7 |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
JOHN J VOZELLA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/06/2007 |
Decision Date | 09/18/2007 |
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
|
|
|