Device Classification Name |
Culdoscope (And Accessories)
|
510(k) Number |
K143308 |
Device Name |
GelPOINT Transvaginal Access Platform |
Applicant |
APPLIED MEDICAL RESOURCES |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
Frans VandenBroek |
Correspondent |
APPLIED MEDICAL RESOURCES |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
Frans VandenBroek |
Regulation Number | 884.1640
|
Classification Product Code |
|
Date Received | 11/18/2014 |
Decision Date | 10/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|