Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K914153 |
Device Name |
OTT INSUFFLATOR FILTER PLUS/TUBING SET |
Applicant |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
SCOTT C MARLOW |
Correspondent |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
SCOTT C MARLOW |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 09/16/1991 |
Decision Date | 04/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|