Blood Bank Supplies

Supplies, Blood-bank

Fenwal Inc

The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Blood Bank Supplies.

Pre-market Notification Details

Device IDBK960083
510k NumberBK960083
Device Name:Blood Bank Supplies
ClassificationSupplies, Blood-bank
Applicant Fenwal Inc three Corporate Drive Lake Zurich,  IL  60047
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-29
Decision Date1997-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20810020440533 BK960083 0

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.