The following data is part of a premarket notification filed by Needletech Products, Inc. with the FDA for Marromax B One Marrow Aspiration Needle Kit, Models 50083-xx, 50084-xx.
| Device ID | K100665 |
| 510k Number | K100665 |
| Device Name: | MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX |
| Classification | Syringe, Piston |
| Applicant | NEEDLETECH PRODUCTS, INC. 81 WEST ST. Attleboro, MA 02703 |
| Contact | Rick Tripp |
| Correspondent | Rick Tripp NEEDLETECH PRODUCTS, INC. 81 WEST ST. Attleboro, MA 02703 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2010-06-24 |