Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K970712 |
Device Name |
LAPARO-TENSER |
Applicant |
L & T S.N.C. DI E. LUCINI & C. |
20037 PADERNO DUGNANO |
VIA E. MAHEI 17/19 |
MILANO,
IT
|
|
Applicant Contact |
FLAVIO LUCINI |
Correspondent |
L & T S.N.C. DI E. LUCINI & C. |
20037 PADERNO DUGNANO |
VIA E. MAHEI 17/19 |
MILANO,
IT
|
|
Correspondent Contact |
FLAVIO LUCINI |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 02/26/1997 |
Decision Date | 07/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|