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 With T-handle.
| Device ID | K120002 |
| 510k Number | K120002 |
| Device Name: | I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE |
| Classification | Instrument, Biopsy |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. 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 | 2012-01-03 |
| Decision Date | 2012-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10849233013893 | K120002 | 000 |