Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K941507 |
FOIA Releasable 510(k) |
K941507
|
Device Name |
THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM |
Applicant |
SANESE MEDICAL CORP. |
885 NORTHWEST BLVD. |
COLUMBUS,
OH
43212
|
|
Applicant Contact |
CHRISTOPHER N SANESE |
Correspondent |
SANESE MEDICAL CORP. |
885 NORTHWEST BLVD. |
COLUMBUS,
OH
43212
|
|
Correspondent Contact |
CHRISTOPHER N SANESE |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 03/29/1994 |
Decision Date | 03/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|