The following data is part of a premarket notification filed by H.s. Hospital Services S.p.a. with the FDA for Securcut Aspiration Biopsy Needle.
| Device ID | K013071 |
| 510k Number | K013071 |
| Device Name: | SECURCUT ASPIRATION BIOPSY NEEDLE |
| 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 | 2001-09-13 |
| Decision Date | 2001-12-12 |
| Summary: | summary |