The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Healthline Medicator / Redineb Aerosol Drug Delivery System.
| Device ID | K082541 |
| 510k Number | K082541 |
| Device Name: | HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDI NUCLEAR CORP., INC. 4610 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Jerry Schoen |
| Correspondent | Jerry Schoen MEDI NUCLEAR CORP., INC. 4610 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-11-26 |
| Summary: | summary |