Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K082710 |
Device Name |
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET |
Applicant |
NEOCHILD, LLC |
4605 N/ STILES |
OKLAHOMA CITY,
OK
73105
|
|
Applicant Contact |
RHETT BOLEN |
Correspondent |
NEOCHILD, LLC |
4605 N/ STILES |
OKLAHOMA CITY,
OK
73105
|
|
Correspondent Contact |
RHETT BOLEN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/16/2008 |
Decision Date | 01/23/2009 |
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 |
Yes
|
|
|