Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K120012 |
Device Name |
INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS |
Applicant |
INTEGRA LIFESCIENCES CORPORATION |
589 DAVIES DRIVE |
YORK,
PA
17402
|
|
Applicant Contact |
STEPHANIE SHEESLEY |
Correspondent |
INTEGRA LIFESCIENCES CORPORATION |
589 DAVIES DRIVE |
YORK,
PA
17402
|
|
Correspondent Contact |
STEPHANIE SHEESLEY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/03/2012 |
Decision Date | 09/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|