Platelet And Plasma Separator For Bone Graft Handling

Platelet And Plasma Separator For Bone Graft Handling

Suneva Medical, Inc.

The following data is part of a premarket notification filed by Suneva Medical, Inc. with the FDA for Platelet And Plasma Separator For Bone Graft Handling.

Pre-market Notification Details

Device IDBK200477
510k NumberBK200477
Device Name:Platelet And Plasma Separator For Bone Graft Handling
ClassificationPlatelet And Plasma Separator For Bone Graft Handling
Applicant Suneva Medical, Inc. 5870 Pacific Center Blvd San Diego,  CA  92121
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-10
Decision Date2020-09-30

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