The following data is part of a premarket notification filed by Entracare Corp. with the FDA for Nutricare Enteral Feeding Tube.
Device ID | K925261 |
510k Number | K925261 |
Device Name: | NUTRICARE ENTERAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | ENTRACARE CORP. 15731 WEST 100TH TERRACE Lenexa, KS 66219 |
Contact | Al Boedeker |
Correspondent | Al Boedeker ENTRACARE CORP. 15731 WEST 100TH TERRACE Lenexa, KS 66219 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-19 |
Decision Date | 1994-02-17 |