The following data is part of a premarket notification filed by Harvest Technologies, Corp. with the FDA for Smartjet Bone Graft Liquid Applicator (spray Tip), Model Sk/s, Smartjet Bone Graft Liquid Applicator (dual Lumen Cannula.
| Device ID | K011032 |
| 510k Number | K011032 |
| Device Name: | SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD. Plymouth, MA 02360 |
| Contact | Annette Fagnant |
| Correspondent | Annette Fagnant HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD. Plymouth, MA 02360 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-07-03 |