The following data is part of a premarket notification filed by Footprint Medical with the FDA for Footprint Medical Silicone Feeding Tube.
Device ID | K090559 |
510k Number | K090559 |
Device Name: | FOOTPRINT MEDICAL SILICONE FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | FOOTPRINT MEDICAL 1203 CAMDEN ST. San Antonio, TX 78215 |
Contact | Clyde Baker |
Correspondent | Clyde Baker FOOTPRINT MEDICAL 1203 CAMDEN ST. San Antonio, TX 78215 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-02 |
Decision Date | 2009-05-04 |