Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K123659 |
Device Name |
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) |
Applicant |
ACTUATED MEDICAL, INC. |
310 ROLLING RIDGE DR |
BELLEFONTE,
PA
16823
|
|
Applicant Contact |
DEBORA DEMERS, PHD |
Correspondent |
ACTUATED MEDICAL, INC. |
310 ROLLING RIDGE DR |
BELLEFONTE,
PA
16823
|
|
Correspondent Contact |
DEBORA DEMERS, PHD |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 11/28/2012 |
Decision Date | 12/20/2012 |
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
|
|
|