The following data is part of a premarket notification filed by Kentec Medical, Inc. with the FDA for Ameritus Entral (tm) Enteral Feeding Tube.
| Device ID | K100526 |
| 510k Number | K100526 |
| Device Name: | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE |
| Classification | Tube, Feeding |
| Applicant | KENTEC MEDICAL, INC. 17871 FITCH Irvine, CA 92614 -6001 |
| Contact | Keith Rooks |
| Correspondent | Keith Rooks KENTEC MEDICAL, INC. 17871 FITCH Irvine, CA 92614 -6001 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-24 |
| Decision Date | 2010-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817522013101 | K100526 | 000 |
| 30817522012364 | K100526 | 000 |
| 30817522012357 | K100526 | 000 |