The following data is part of a premarket notification filed by Promedical Ltd. with the FDA for Jamshidi Style Biopsy Needle (acri) (biomid), Illinois Style Biopsy Needle (isan).
| Device ID | K952350 |
| 510k Number | K952350 |
| Device Name: | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) |
| Classification | Bone Marrow Collection/transfusion Kit |
| 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 | LWE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-19 |
| Decision Date | 1995-07-17 |