The following data is part of a premarket notification filed by Harvest Technologies, Llc. with the FDA for Smartcell Processing System.
| Device ID | K983022 |
| 510k Number | K983022 |
| Device Name: | SMARTCELL PROCESSING SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | HARVEST TECHNOLOGIES, LLC. 77 ACCORD PARK DR. D-7 Norwell, MA 02061 |
| Contact | Richard Lariviere |
| Correspondent | Richard Lariviere HARVEST TECHNOLOGIES, LLC. 77 ACCORD PARK DR. D-7 Norwell, MA 02061 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-31 |
| Decision Date | 1999-04-02 |
| Summary: | summary |