The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex Enteral Delivery Pump Set With Spike (1000ml), Dynarex Enteral Feeding Sets For Gravity And Pump Use (1000ml).
| Device ID | K082863 |
| 510k Number | K082863 |
| Device Name: | DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Contact | James Hurlman |
| Correspondent | James Hurlman DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2009-01-09 |
| Summary: | summary |