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 .
| Device ID | BK170136 |
| 510k Number | BK170136 |
| 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 |
| Classification | Platelet And Plasma Separator For Bone Graft Handling |
| Applicant | Healeon Medical, Inc. 1111 Rancho Conejo Blvd #204 Newbury Park, CA 91320 US |
| Product Code | ORG |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-25 |
| Decision Date | 2018-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850034511559 | BK170136 | 0 |
| 00850060751134 | BK170136 | 0 |
| 00850060751165 | BK170136 | 0 |
| 00850060751172 | BK170136 | 0 |
| 00850034511955 | 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 |
| 00850060751127 | BK170136 | 0 |