Device Classification Name |
Anoscope And Accessories
|
510(k) Number |
K171701 |
Device Name |
GelPOINT Path Transanal Access Platform |
Applicant |
Applied Medical Resources Corp. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
Corinne Weisheit |
Correspondent |
Applied Medical Resources Corp. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
Corinne Weisheit |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/08/2017 |
Decision Date | 07/20/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|