The following data is part of a premarket notification filed by H.s. Hospital Service S.r.l. with the FDA for Bmn I Type Marrow Aspiration Needle.
| Device ID | K020987 |
| 510k Number | K020987 |
| Device Name: | BMN I TYPE MARROW ASPIRATION NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | H.S. HOSPITAL SERVICE S.R.L. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Contact | Lucio Improta |
| Correspondent | Lucio Improta H.S. HOSPITAL SERVICE S.R.L. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-27 |
| Decision Date | 2002-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033003343549 | K020987 | 000 |
| 38033003343488 | K020987 | 000 |