The following data is part of a premarket notification filed by Medical Molding Corp. Of America with the FDA for Misty Ox Dispos. Nebulizer.
| Device ID | K841469 |
| 510k Number | K841469 |
| Device Name: | MISTY OX DISPOS. NEBULIZER |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | MEDICAL MOLDING CORP. OF AMERICA 1611 Babcock Newport Beach, CA 92663 |
| Contact | Terry Bagwell |
| Correspondent | Terry Bagwell MEDICAL MOLDING CORP. OF AMERICA 1611 Babcock Newport Beach, CA 92663 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-09 |
| Decision Date | 1984-04-24 |