The following data is part of a premarket notification filed by Entracon Corp. with the FDA for Sentinel Enteral Feeding Pump, Lh2001 Enteral Feeding Pump.
| Device ID | K011587 |
| 510k Number | K011587 |
| Device Name: | SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP |
| Classification | Pump, Infusion, Enteral |
| Applicant | ENTRACON CORP. 22 WINDSOR DR. Foxborough, MA 02035 |
| Contact | Paul Zannechia |
| Correspondent | Donald J Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-05-23 |
| Decision Date | 2001-06-01 |
| Summary: | summary |