The following data is part of a premarket notification filed by Hsiner Co., Ltd. with the FDA for Hsiner Jet Nebulizer, Model Hs-31100.
| Device ID | K052811 |
| 510k Number | K052811 |
| Device Name: | HSINER JET NEBULIZER, MODEL HS-31100 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2005-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822383504275 | K052811 | 000 |
| M368GF614002 | K052811 | 000 |
| M368GF640952 | K052811 | 000 |
| M368JB01120612 | K052811 | 000 |
| M368JB01120622 | K052811 | 000 |
| M368JB01120672 | K052811 | 000 |
| M368JB01120702 | K052811 | 000 |
| M368JB01121642 | K052811 | 000 |
| 00822383134314 | K052811 | 000 |
| 00822383134321 | K052811 | 000 |
| 10822383134311 | K052811 | 000 |
| 10822383134328 | K052811 | 000 |
| 10822383268283 | K052811 | 000 |
| 10822383268290 | K052811 | 000 |
| 10822383504268 | K052811 | 000 |
| M368GF613992 | K052811 | 000 |