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 |