510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Platelet And Plasma Separator For Bone Graft Handling

Cascade Medical Enterprises, LLC

The following data is part of a premarket notification filed by Cascade Medical Enterprises, Llc with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK170096
510k NumberBK170096
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationPlatelet And Plasma Separator For Bone Graft Handling
Applicant Cascade Medical Enterprises, LLC 20 Greenup Court Wayne,  NJ  07470 US
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-23
Decision Date2017-11-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30851802007107 BK170096 0
30851802007091 BK170096 0
00851802007120 BK170096 0
00851802007113 BK170096 0

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.