The following data is part of a premarket notification filed by Promedical Ltd. with the FDA for Pro-b Core-rect Coaxial Biopsy System.
| Device ID | K954596 |
| 510k Number | K954596 |
| Device Name: | PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM |
| Classification | Biopsy Needle |
| Applicant | PROMEDICAL LTD. 240 BRAEN AVE. Wyckoff, NJ 07481 |
| Contact | Henry V Sierakowski |
| Correspondent | Henry V Sierakowski PROMEDICAL LTD. 240 BRAEN AVE. Wyckoff, NJ 07481 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-03 |
| Decision Date | 1995-10-07 |