The following data is part of a premarket notification filed by Harvest Technologies 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 | BK120038 |
| 510k Number | BK120038 |
| 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 | Harvest Technologies 40 Grissom Road Plymouth, MA 02360 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 | 2012-06-25 |
| Decision Date | 2012-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35020583514363 | BK120038 | 0 |
| 05020583514010 | BK120038 | 0 |
| 05020583514362 | BK120038 | 0 |
| 05020583514157 | BK120038 | 0 |
| 05020583514140 | BK120038 | 0 |
| 05020583514096 | BK120038 | 0 |
| 05020583514089 | BK120038 | 0 |
| 05020583514072 | BK120038 | 0 |
| 05020583514065 | BK120038 | 0 |
| 05020583514058 | BK120038 | 0 |
| 05020583514041 | BK120038 | 0 |
| 05020583514027 | BK120038 | 0 |
| 05020583514034 | BK120038 | 0 |
| 35020583514004 | BK120038 | 0 |
| 35020583514158 | BK120038 | 0 |
| 35020583514141 | BK120038 | 0 |
| 35020583514097 | BK120038 | 0 |
| 35020583514080 | BK120038 | 0 |
| 35020583514073 | BK120038 | 0 |
| 35020583514066 | BK120038 | 0 |
| 35020583514059 | BK120038 | 0 |
| 35020583514042 | BK120038 | 0 |
| 35020583514035 | BK120038 | 0 |
| 35020583514028 | BK120038 | 0 |
| 35020583514011 | BK120038 | 0 |
| 05020583514003 | BK120038 | 0 |