The following data is part of a premarket notification filed by Entracare, Llc with the FDA for Skin Level Gastrostomy Tube Kit (ecsl).
| Device ID | K041034 |
| 510k Number | K041034 |
| Device Name: | SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ENTRACARE, LLC 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland ENTRACARE, LLC 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-21 |
| Decision Date | 2004-08-31 |
| Summary: | summary |