Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K133272 |
Device Name |
VERSACUT + TISSUE MORCELLATOR |
Applicant |
LUMENIS LTD. |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
LUMENIS LTD. |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/24/2013 |
Decision Date | 05/13/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|