Pre-market Notification Details
Device ID | BK040076 |
510k Number | BK040076 |
Device Name: | Transfer Sets |
Classification | Set, Transfer (blood/plasma) |
Applicant | Fresenius Medical Care North America 95 Hayden Avenue Lexington, MA 02420 US |
Product Code | KSB |
CFR Regulation Number | 864.9875 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-13 |
Decision Date | 2004-12-17 |
NIH GUDID Devices
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