The following data is part of a premarket notification filed by Neochild, Llc with the FDA for Safechild Enteral Feeding Tube And Accessories And Feeding Tube Extension Set.
Device ID | K082710 |
510k Number | K082710 |
Device Name: | SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | NEOCHILD, LLC 4605 N/ STILES Oklahoma City, OK 73105 |
Contact | Rhett Bolen |
Correspondent | Rhett Bolen NEOCHILD, LLC 4605 N/ STILES Oklahoma City, OK 73105 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2008-09-16 |
Decision Date | 2009-01-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10816336022244 | K082710 | 000 |
20816336022609 | K082710 | 000 |
20816336022388 | K082710 | 000 |
02081633602005 | K082710 | 000 |