The following data is part of a premarket notification filed by Kendall with the FDA for Next Generation Salem Sump.
| Device ID | K040388 |
| 510k Number | K040388 |
| Device Name: | NEXT GENERATION SALEM SUMP |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Jim Welsh |
| Correspondent | Jim Welsh KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FEG |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521004542 | K040388 | 000 |