The following data is part of a premarket notification filed by Novartis Nutrition Corp. with the FDA for Compat Dualflo Enteral Delivery Pump Set With Spikeright Piercing Spike And 1000 Ml Waer Bag.
| Device ID | K080340 |
| 510k Number | K080340 |
| Device Name: | COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | NOVARTIS NUTRITION CORP. 12500 WHITEWATER DRIVE Minnetonka, MN 55343 |
| Contact | Thomas A Dold |
| Correspondent | Thomas A Dold NOVARTIS NUTRITION CORP. 12500 WHITEWATER DRIVE Minnetonka, MN 55343 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-08 |
| Decision Date | 2008-03-05 |
| Summary: | summary |