The following data is part of a premarket notification filed by H.s. Hospital Service S.r.l. with the FDA for Precisa Biopsy Needle.
| Device ID | K002944 |
| 510k Number | K002944 |
| Device Name: | PRECISA 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 |
|---|---|---|
| 28033003345355 | K002944 | 000 |
| 38033003345284 | K002944 | 000 |
| 38033003345314 | K002944 | 000 |
| 28033003345171 | K002944 | 000 |
| 28033003345195 | K002944 | 000 |
| 28033003345201 | K002944 | 000 |
| 28033003345232 | K002944 | 000 |
| 28033003345249 | K002944 | 000 |
| 28033003345256 | K002944 | 000 |
| 28033003345300 | K002944 | 000 |
| 28033003345324 | K002944 | 000 |
| 08033003345337 | K002944 | 000 |
| 38033003345215 | K002944 | 000 |