The following data is part of a premarket notification filed by Harvest Technologies, Corp. with the FDA for Smartprep2 Bmac System, Smartprep Platelet Concentration System.
| Device ID | K103340 |
| 510k Number | K103340 |
| Device Name: | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Contact | John D Bonasera |
| Correspondent | John D Bonasera HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-15 |
| Decision Date | 2010-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05020583514485 | K103340 | 000 |
| 05020583514256 | K103340 | 000 |
| 05020583514270 | K103340 | 000 |
| 05020583514294 | K103340 | 000 |
| 05020583514300 | K103340 | 000 |
| 35020583514165 | K103340 | 000 |
| 35020583514172 | K103340 | 000 |
| 35020583514189 | K103340 | 000 |
| 35020583514202 | K103340 | 000 |
| 05020583514249 | K103340 | 000 |
| 05020583514232 | K103340 | 000 |
| 05020583514478 | K103340 | 000 |
| 05020583514287 | K103340 | 000 |
| 05020583514164 | K103340 | 000 |
| 05020583514171 | K103340 | 000 |
| 05020583514188 | K103340 | 000 |
| 05020583514201 | K103340 | 000 |
| 05020583514218 | K103340 | 000 |
| 05020583514225 | K103340 | 000 |
| 35020583514219 | K103340 | 000 |
| 35020583514226 | K103340 | 000 |
| 35020583514233 | K103340 | 000 |
| 05020583514881 | K103340 | 000 |
| 05020583514898 | K103340 | 000 |
| 05020583514904 | K103340 | 000 |
| 05020583514911 | K103340 | 000 |
| 05020583514928 | K103340 | 000 |
| 05020583514935 | K103340 | 000 |
| 05020583514942 | K103340 | 000 |
| 05020583514959 | K103340 | 000 |
| 05020583514874 | K103340 | 000 |
| 05020583514867 | K103340 | 000 |
| 35020583514240 | K103340 | 000 |
| 35020583514257 | K103340 | 000 |
| 35020583514271 | K103340 | 000 |
| 35020583514288 | K103340 | 000 |
| 35020583514295 | K103340 | 000 |
| 35020583514301 | K103340 | 000 |
| 35020583514479 | K103340 | 000 |
| 35020583514486 | K103340 | 000 |
| 05020583514980 | K103340 | 000 |