The following data is part of a premarket notification filed by H.s. Hospital Services S.p.a. with the FDA for Hs Nota.
| Device ID | K131925 |
| 510k Number | K131925 |
| Device Name: | HS NOTA |
| Classification | Biopsy Needle |
| Applicant | H.S. HOSPITAL SERVICES S.P.A. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Contact | Lucio Improta |
| Correspondent | Lucio Improta H.S. HOSPITAL SERVICES S.P.A. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2014-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033055146945 | K131925 | 000 |
| 38033055146914 | K131925 | 000 |
| 08033055146920 | K131925 | 000 |
| 38058983744803 | K131925 | 000 |
| 38058983744797 | K131925 | 000 |
| 38058983744780 | K131925 | 000 |
| 38058983744094 | K131925 | 000 |
| 38058983744063 | K131925 | 000 |
| 38033055146969 | K131925 | 000 |