The following data is part of a premarket notification filed by Hsiner Co., Ltd. with the FDA for Hsiner Nebulizer Bottle, Cpr Masks And Face Shields.
| Device ID | K082009 |
| 510k Number | K082009 |
| Device Name: | HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HSINER CO., LTD. 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks HSINER CO., LTD. 29201 VIA NORTE Temecula, CA 92591 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2008-08-22 |
| Summary: | summary |