The following data is part of a premarket notification filed by Medax Srl Unipersonale with the FDA for Med-i Bone Marrow Aspiration Needle, Med-s Bone Marrow Aspiration Needle, Med-l Bone Marrow Biopsy And Aspiration System, Med-b Bone Marrow Biopsy System, Med-j Bone Marrow Biopsy And Aspiration System.
| Device ID | K192099 |
| 510k Number | K192099 |
| Device Name: | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy And Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy And Aspiration System |
| Classification | Instrument, Biopsy |
| Applicant | Medax Srl Unipersonale Via R.Piva, 1/A Poggio Rusco, IT 46025 |
| Contact | Stefano Cavalieri |
| Correspondent | Stefano Cavalieri Gemarmed S.R.L Via R. Piva 1/A Poggio Rusco, IT 46025 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2020-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054301668703 | K192099 | 000 |
| 18052283956092 | K192099 | 000 |
| 18052283956085 | K192099 | 000 |
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| 18052283956047 | K192099 | 000 |
| 18052283955941 | K192099 | 000 |
| 18052283955934 | K192099 | 000 |
| 18052283955927 | K192099 | 000 |
| 18052283955910 | K192099 | 000 |
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| 18052283955750 | K192099 | 000 |
| 18052283955743 | K192099 | 000 |
| 18052283955736 | K192099 | 000 |
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| 18052283955712 | K192099 | 000 |
| 18052283956153 | K192099 | 000 |
| 18052283956146 | K192099 | 000 |
| 18052283956139 | K192099 | 000 |
| 18052283955859 | K192099 | 000 |