The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Bone Marrow Aspiration Syringe.
| Device ID | K051720 |
| 510k Number | K051720 |
| Device Name: | SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE |
| Classification | Syringe, Piston |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-27 |
| Decision Date | 2005-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98171015199S0 | K051720 | 000 |
| H98171015099S0 | K051720 | 000 |
| H98171011199S0 | K051720 | 000 |
| H67971015197S0 | K051720 | 000 |
| H67971015097S0 | K051720 | 000 |
| H67971011197S0 | K051720 | 000 |