The following data is part of a premarket notification filed by Mps Acacia with the FDA for Mps Acacia Enteral Feeding Tube.
Device ID | K080328 |
510k Number | K080328 |
Device Name: | MPS ACACIA ENTERAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MPS ACACIA 785 CHALLENGER ST. Brea, CA 92821 |
Contact | Fergie Ferguson |
Correspondent | Fergie Ferguson MPS ACACIA 785 CHALLENGER ST. Brea, CA 92821 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-07 |
Decision Date | 2008-05-14 |
Summary: | summary |