The following data is part of a premarket notification filed by Diemolding Corp. with the FDA for Medshield/aerochamber.
| Device ID | K961455 |
| 510k Number | K961455 |
| Device Name: | MEDSHIELD/AEROCHAMBER |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | DIEMOLDING CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DIEMOLDING CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-16 |
| Decision Date | 1996-07-25 |
| Summary: | summary |