The following data is part of a premarket notification filed by Harvest Technologies, Llc. with the FDA for Harvest Technologies Dual Liquid Applicator, Model Sk/s: Harvest Dual Liquid Applicator Lk/2.
| Device ID | K000456 |
| 510k Number | K000456 |
| Device Name: | HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 |
| Classification | Syringe, Piston |
| Applicant | HARVEST TECHNOLOGIES, LLC. 77 ACCORD PARK DR. D-7 Norwell, MA 02061 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant HARVEST TECHNOLOGIES, LLC. 77 ACCORD PARK DR. D-7 Norwell, MA 02061 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-06-01 |