The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Enteral Administration Set.
Device ID | K870623 |
510k Number | K870623 |
Device Name: | ENTERAL ADMINISTRATION SET |
Classification | Tube, Feeding |
Applicant | PLASCO, INC. 3849 SWANSON ST. Gurnee, IL 60031 -1225 |
Contact | Michael S Feles |
Correspondent | Michael S Feles PLASCO, INC. 3849 SWANSON ST. Gurnee, IL 60031 -1225 |
Product Code | FPD |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-12 |
Decision Date | 1987-06-26 |