Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K900878 |
Device Name |
OTT INSUFFLATION FILTER TUBING |
Applicant |
GYNESCOPE CORP. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
SCOTT C MARLOW |
Correspondent |
GYNESCOPE CORP. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
SCOTT C MARLOW |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 02/26/1990 |
Decision Date | 05/07/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|