The following data is part of a premarket notification filed by Ross Product Div. Abbott Laboratories with the FDA for Flexiflo Enteral Feeding Tube.
Device ID | K992494 |
510k Number | K992494 |
Device Name: | FLEXIFLO ENTERAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | ROSS PRODUCT DIV. ABBOTT LABORATORIES 625 CLEVELAND AVENUE Columbus, OH 43215 |
Contact | Daniel Hamilton |
Correspondent | Daniel Hamilton ROSS PRODUCT DIV. ABBOTT LABORATORIES 625 CLEVELAND AVENUE Columbus, OH 43215 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-26 |
Decision Date | 1999-08-25 |