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Platelet And Plasma Separator For Bone Graft Handling

Haeleon Medical, Inc.

The following data is part of a premarket notification filed by Haeleon Medical, Inc. 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 IDBK200449
510k NumberBK200449
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 Haeleon Medical, Inc. 1090 Lawrence Dr Newbury Park,  CA  91320 US
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-27
Decision Date2020-08-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850034511887 BK200449 0
00850034511900 BK200449 0

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