The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Dispenser Dp 20.
| Device ID | K071588 |
| 510k Number | K071588 |
| Device Name: | DISPENSER DP 20 |
| Classification | Pump, Infusion |
| Applicant | NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Contact | Erich Forster |
| Correspondent | Erich Forster NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-11 |
| Decision Date | 2007-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787114091011 | K071588 | 000 |
| ENOU1513TVS0 | K071588 | 000 |
| ENOU1513NOU0 | K071588 | 000 |
| ENOU1511NOU0 | K071588 | 000 |
| ENOU1501TVS0 | K071588 | 000 |
| ENOU1501NOU0 | K071588 | 000 |
| ENOU4180230ANG0 | K071588 | 000 |
| H7871140900123000 | K071588 | 000 |
| H7871140900111000 | K071588 | 000 |
| 10884521140417 | K071588 | 000 |
| ENOU4187US0 | K071588 | 000 |
| ENOU4186US0 | K071588 | 000 |
| ENOU4181US0 | K071588 | 000 |
| ENOU4180US0 | K071588 | 000 |
| ENOU4163US0 | K071588 | 000 |
| ENOU4161US0 | K071588 | 000 |
| ENOU1527NOU0 | K071588 | 000 |
| ENOU41610 | K071588 | 000 |
| ENOU6022VNUS9 | K071588 | 000 |
| ENOU6022EXC9 | K071588 | 000 |
| ENOU6022ANG9 | K071588 | 000 |
| H787114090020 | K071588 | 000 |
| H787114090012300 | K071588 | 000 |
| H787114090011100 | K071588 | 000 |
| ENOU4187TVS0 | K071588 | 000 |
| ENOU4187COV0 | K071588 | 000 |
| ENOU41870 | K071588 | 000 |
| ENOU41860 | K071588 | 000 |
| ENOU41810 | K071588 | 000 |
| ENOU4180TVS0 | K071588 | 000 |
| ENOU41800 | K071588 | 000 |
| ENOU4163TVS0 | K071588 | 000 |
| ENOU41630 | K071588 | 000 |
| 10884521140424 | K071588 | 000 |