The following data is part of a premarket notification filed by Cascade Medical Enterprises, Llc with the FDA for Blood Bank Supplies.
Device ID | BK060006 |
510k Number | BK060006 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Cascade Medical Enterprises, LLC 20 Greenup Court Wayne, NJ 07470 US |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-30 |
Decision Date | 2006-02-16 |