Device Classification Name |
endoscopic tissue approximation device
|
510(k) Number |
K070671 |
Device Name |
OPUS SMARTSTITCH SUTURE DEVICE |
Applicant |
ARTHROCARE CORP. |
15285 ALTON PARKWAY, #200 |
IRVINE,
CA
92618
|
|
Applicant Contact |
LAURA N KASPEROWICZ |
Correspondent |
ARTHROCARE CORP. |
15285 ALTON PARKWAY, #200 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
LAURA N KASPEROWICZ |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/12/2007 |
Decision Date | 04/06/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|