Device Classification Name |
Light Source, Endoscope, Xenon Arc
|
510(k) Number |
K913586 |
Device Name |
MARLOW VERRES NEEDLES |
Applicant |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
SCOTT MARLOW |
Correspondent |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
SCOTT MARLOW |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/12/1991 |
Decision Date | 10/08/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|