The following data is part of a premarket notification filed by Leventon, S.a. with the FDA for Dosi-flow, Models 20 & 30.
| Device ID | K952810 |
| 510k Number | K952810 |
| Device Name: | DOSI-FLOW, MODELS 20 & 30 |
| Classification | Set, Administration, Intravascular |
| Applicant | LEVENTON, S.A. POLIGONO CAN SUYER, 11 SANT ANDREU DE LA BARCA Barcelona, ES 08740 |
| Contact | Joaquim Soriano |
| Correspondent | Joaquim Soriano LEVENTON, S.A. POLIGONO CAN SUYER, 11 SANT ANDREU DE LA BARCA Barcelona, ES 08740 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1995-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18436020761703 | K952810 | 000 |
| 18436020769181 | K952810 | 000 |
| 08436020768828 | K952810 | 000 |
| 08436020768835 | K952810 | 000 |
| 08436020769207 | K952810 | 000 |
| 18436020760560 | K952810 | 000 |
| 18436020761369 | K952810 | 000 |
| 18436020763462 | K952810 | 000 |
| 18436020764254 | K952810 | 000 |
| 18436020769174 | K952810 | 000 |