The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for I-style Bone Marrow Aspiration Needle.
| Device ID | K061570 |
| 510k Number | K061570 |
| Device Name: | I-STYLE BONE MARROW ASPIRATION NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DRIVE P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DRIVE P.O. BOX 11067 Hauppauge, NY 11788 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-06 |
| Decision Date | 2006-07-03 |
| Summary: | summary |