The following data is part of a premarket notification filed by Dhd Diemolding Healthcare Div. with the FDA for Stealth, Metered Dose Inhaler (mdi) Spacer Without Integral Actuator.
| Device ID | K973532 |
| 510k Number | K973532 |
| Device Name: | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DHD DIEMOLDING HEALTHCARE DIV. MADISON ST. Wampsville, NY 13163 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DHD DIEMOLDING HEALTHCARE DIV. MADISON ST. Wampsville, NY 13163 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1998-03-19 |