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Platelet And Plasma Separator For Bone Graft Handling

Healeon Medical, Inc.

The following data is part of a premarket notification filed by Healeon 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 IDBK170136
510k NumberBK170136
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 Healeon Medical, Inc. 1111 Rancho Conejo Blvd #204 Newbury Park,  CA  91320 US
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-25
Decision Date2018-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850034511559 BK170136 0
00850034511979 BK170136 0
00850034511221 BK170136 0
00850034511474 BK170136 0
10850034511310 BK170136 0
00850034511405 BK170136 0
00850034511498 BK170136 0
00850034511443 BK170136 0
00850034511429 BK170136 0
00850034511832 BK170136 0
00850034511535 BK170136 0
00850034511955 BK170136 0

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