The following data is part of a premarket notification filed by H.s. Hospital Service S.r.l. with the FDA for Biomol Aspiration Biopsy Needle.
| Device ID | K002947 |
| 510k Number | K002947 |
| Device Name: | BIOMOL ASPIRATION BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | H.S. HOSPITAL SERVICE S.R.L. 131 HIGHWAY DR. South Glastonbury, CT 06073 |
| Contact | Lucio Improta |
| Correspondent | Lucio Improta H.S. HOSPITAL SERVICE S.R.L. 131 HIGHWAY DR. South Glastonbury, CT 06073 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-21 |
| Decision Date | 2000-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28033003340770 | K002947 | 000 |
| 28033003340701 | K002947 | 000 |
| 38033003340555 | K002947 | 000 |
| 38033003340722 | K002947 | 000 |
| 08033003340714 | K002947 | 000 |
| 08033003340660 | K002947 | 000 |
| 38033003340654 | K002947 | 000 |
| 38033003340647 | K002947 | 000 |