The following data is part of a premarket notification filed by Busse Hospital Disposables with the FDA for J-style Bone Marrow Biopsy / Aspiration Needle With Snare-it Marrow Acquisition Cannula.
| Device ID | K110883 |
| 510k Number | K110883 |
| Device Name: | J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA |
| Classification | Instrument, Biopsy |
| Applicant | BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE 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 | 2011-03-30 |
| Decision Date | 2011-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849233014213 | K110883 | 000 |
| 00849233001787 | K110883 | 000 |
| 00849233002524 | K110883 | 000 |
| 00849233009929 | K110883 | 000 |
| 00849233009943 | K110883 | 000 |
| 00849233009950 | K110883 | 000 |
| 00849233009967 | K110883 | 000 |
| 00849233013179 | K110883 | 000 |
| 10849233013831 | K110883 | 000 |
| 00849233013841 | K110883 | 000 |
| 00849233001770 | K110883 | 000 |