Device Classification Name |
pump, air, non-manual, for endoscope
|
510(k) Number |
K153588 |
Device Name |
EndoChoice Water Bottle Cap System |
Applicant |
ENDOCHOICE, INC. |
11810 WILLS RD. |
ALPHARETTA,
GA
30009
|
|
Applicant Contact |
Daniel Hoefer |
Correspondent |
ENDOCHOICE, INC. |
11810 WILLS RD. |
ALPHARETTA,
GA
30009
|
|
Correspondent Contact |
Daniel Hoefer |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/16/2015 |
Decision Date | 02/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|