The following data is part of a premarket notification filed by Hsiner Co., Ltd. with the FDA for 70530-bactial/viral Filter, 70531-hmef, 70536-bacterial/viral Filter.
| Device ID | K091185 |
| 510k Number | K091185 |
| Device Name: | 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14712688057445 | K091185 | 000 |
| 14712680057436 | K091185 | 000 |