The following data is part of a premarket notification filed by Nsr Comercio E Representacoes Ltda with the FDA for Nevoni Classic, Model 6600-po.
| Device ID | K082878 |
| 510k Number | K082878 |
| Device Name: | NEVONI CLASSIC, MODEL 6600-PO |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | NSR COMERCIO E REPRESENTACOES LTDA 11 PERRY DRIVE UNIT G Foxboro, MA 02035 |
| Contact | Polly Scherman |
| Correspondent | Polly Scherman NSR COMERCIO E REPRESENTACOES LTDA 11 PERRY DRIVE UNIT G Foxboro, MA 02035 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2008-12-30 |
| Summary: | summary |