The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Enternal Feeding Tube.
Device ID | K832293 |
510k Number | K832293 |
Device Name: | ENTERNAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-13 |
Decision Date | 1983-09-12 |