The following data is part of a premarket notification filed by Harvest Technologies, Corp. with the FDA for Harvest Graft Delivery Syringe.
| Device ID | K043261 |
| 510k Number | K043261 |
| Device Name: | HARVEST GRAFT DELIVERY SYRINGE |
| Classification | Syringe, Piston |
| Applicant | HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Contact | Jack Bonasera |
| Correspondent | Jack Bonasera HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-24 |
| Decision Date | 2005-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35020583514493 | K043261 | 000 |
| 05020583514492 | K043261 | 000 |