The following data is part of a premarket notification filed by Alliance Partners, Llc with the FDA for Swannshidi Bone Marrow Aspiration Needle.
| Device ID | K121181 |
| 510k Number | K121181 |
| Device Name: | SWANNSHIDI BONE MARROW ASPIRATION NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | ALLIANCE PARTNERS, LLC 33490 PIN OAK PARKWAY Avon Lake, OH 44012 |
| Contact | Jennifer Palinchik |
| Correspondent | Jennifer Palinchik ALLIANCE PARTNERS, LLC 33490 PIN OAK PARKWAY Avon Lake, OH 44012 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-18 |
| Decision Date | 2012-08-22 |
| Summary: | summary |