The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Resubmitted Radioaerosol Cont. System Mp-963.
| Device ID | K893532 |
| 510k Number | K893532 |
| Device Name: | RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 |
| Classification | Apparatus, Gas-scavenging |
| Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Contact | Jerry Alexander |
| Correspondent | Jerry Alexander MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1989-08-21 |