Device Classification Name |
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
|
510(k) Number |
K003956 |
Device Name |
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 |
Applicant |
C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 |
BILLERICA,
MA
01821
|
|
Applicant Contact |
BETH A ZIS |
Correspondent |
N.V. KEMA |
P.O. BOX 9035 |
6800 ET ARNHEM |
ARNHEM,
NL
|
|
Correspondent Contact |
PETER N RUYS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/21/2000 |
Decision Date | 01/05/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|