Device Classification Name |
pump, air, non-manual, for endoscope
|
510(k) Number |
K163424 |
Device Name |
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON |
Applicant |
United State Endoscopy Group, Inc. |
5976 Heisley Rd. |
Mentor,
OH
44060
|
|
Applicant Contact |
Ganga Kolli |
Correspondent |
United State Endoscopy Group, Inc. |
5976 Heisley Rd. |
Mentor,
OH
44060
|
|
Correspondent Contact |
Ganga Kolli |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/06/2016 |
Decision Date | 01/04/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|