The following data is part of a premarket notification filed by Hsiner with the FDA for Hsiner Nebulizer Bottle.
| Device ID | K070948 |
| 510k Number | K070948 |
| Device Name: | HSINER NEBULIZER BOTTLE |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HSINER 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks HSINER 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 | 2007-04-04 |
| Decision Date | 2007-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40080196418320 | K070948 | 000 |