Device Classification Name |
anoscope and accessories
|
510(k) Number |
K133393 |
Device Name |
GELPOINT PATH TRANSANAL ACCESS PLATFORM |
Applicant |
APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
FRANS VANDENBROEK |
Correspondent |
APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
FRANS VANDENBROEK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/05/2013 |
Decision Date | 01/02/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|