The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Nebulizer (direct Patient Interface).
| Device ID | K915075 |
| 510k Number | K915075 |
| Device Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDI NUCLEAR CORP., INC. 4501 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Russell W.king |
| Correspondent | Russell W.king MEDI NUCLEAR CORP., INC. 4501 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 | 1991-11-08 |
| Decision Date | 1992-07-16 |