Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K173317 |
Device Name |
DiLumen C2; DiLumen Tool Mount |
Applicant |
Lumendi, LLC |
253 Post Road West |
Westport,
CT
06880
|
|
Applicant Contact |
Dennis Daniels |
Correspondent |
Hogan Lovells U.S. LLP |
553 13th Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/19/2017 |
Decision Date | 04/17/2018 |
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
|
|
|