The following data is part of a premarket notification filed by Tyco Healthcare/kendall with the FDA for Kendall Epump Enteral Feeding Pump And Enteral Feeding Sets.
| Device ID | K040196 |
| 510k Number | K040196 |
| Device Name: | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS |
| Classification | Pump, Infusion, Enteral |
| Applicant | TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Bridget Gardner |
| Correspondent | Bridget Gardner TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2004-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521022147 | K040196 | 000 |
| 20884521022130 | K040196 | 000 |
| 20884521022109 | K040196 | 000 |
| 10884521155787 | K040196 | 000 |
| 10884521072596 | K040196 | 000 |
| 10884521072565 | K040196 | 000 |
| 10884521072442 | K040196 | 000 |