The following data is part of a premarket notification filed by Dhd Diemolding Healthcare Div. with the FDA for Ace Aerosol Enhancer, Hand Held Oral Inhalation Co.
| Device ID | K926301 |
| 510k Number | K926301 |
| Device Name: | ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DHD DIEMOLDING HEALTHCARE DIV. 125 RASBACH ST. Canastota, NY 13032 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DHD DIEMOLDING HEALTHCARE DIV. 125 RASBACH ST. Canastota, NY 13032 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-15 |
| Decision Date | 1993-07-21 |