The following data is part of a premarket notification filed by Dhd Healthcare Corp. with the FDA for Stealth Pilot Kit/ Stealth Spacer/face Mask Kit.
| Device ID | K981167 |
| 510k Number | K981167 |
| Device Name: | STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DHD HEALTHCARE CORP. ONE 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 | 1998-04-01 |
| Decision Date | 1998-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00349502208034 | K981167 | 000 |
| 00349502208027 | K981167 | 000 |
| 30349502208011 | K981167 | 000 |