The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Gastrostomy Feeding Set.
Device ID | K831631 |
510k Number | K831631 |
Device Name: | GASTROSTOMY FEEDING SET |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | PLASCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-20 |
Decision Date | 1983-08-12 |