The following data is part of a premarket notification filed by Nestle Healthcare Nutrition, Inc. with the FDA for Compat Enteral Delivery Pump Sets.
| Device ID | K140947 |
| 510k Number | K140947 |
| Device Name: | COMPAT ENTERAL DELIVERY PUMP SETS |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | NESTLE HEALTHCARE NUTRITION, INC. 5353 WAYZATA BOULEVARD, SUITE 505 Minneapolis, MN 55416 |
| Contact | M.w.(andy) Anderson |
| Correspondent | M.w.(andy) Anderson NESTLE HEALTHCARE NUTRITION, INC. 5353 WAYZATA BOULEVARD, SUITE 505 Minneapolis, MN 55416 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-09-04 |
| Summary: | summary |