Device Classification Name |
Endoscopic Tissue Approximation Device
|
510(k) Number |
K073671 |
Device Name |
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE |
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 | 12/27/2007 |
Decision Date | 03/26/2008 |
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
|
|
|