Device Classification Name |
Biopsy Needle
|
510(k) Number |
K160423 |
Device Name |
Perineologic Access Needle |
Applicant |
Corbin Clinical Resources, LLC |
12234 Williams Road |
Cumberland,
MD
21502
|
|
Applicant Contact |
Kenneth K. Kleinhenz |
Correspondent |
Corbin Clinical Resources, LLC |
12234 Williams Road |
Cumberland,
MD
21502
|
|
Correspondent Contact |
Kenneth K. Kleinhenz |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 02/16/2016 |
Decision Date | 09/02/2016 |
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
|
|
|