The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Trocar Style Needle/co-axial Introducer Needle.
| Device ID | K954265 |
| 510k Number | K954265 |
| Device Name: | TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-12 |
| Decision Date | 1995-09-29 |