Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K050639 |
Device Name |
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM |
Applicant |
LUMENIS, INC. |
2400 CONDENSA ST. |
SANTA CLARA,
CA
95051 -0901
|
|
Applicant Contact |
MARTHA MURARI |
Correspondent |
LUMENIS, INC. |
2400 CONDENSA ST. |
SANTA CLARA,
CA
95051 -0901
|
|
Correspondent Contact |
MARTHA MURARI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/14/2005 |
Decision Date | 03/31/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|