The following data is part of a premarket notification filed by Kentec Medical, Inc. with the FDA for Ameritus Medical Enteral Feeding Extension Set.
| Device ID | K120272 |
| 510k Number | K120272 |
| Device Name: | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | KENTEC MEDICAL, INC. 17871 FITCH Irvine, CA 92614 -6001 |
| Contact | Keith Rooks |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-01-30 |
| Decision Date | 2012-02-17 |
| Summary: | summary |