The following data is part of a premarket notification filed by Palex Intl. Sa with the FDA for Episensor.
Device ID | K903224 |
510k Number | K903224 |
Device Name: | EPISENSOR |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | PALEX INTL. SA CARRETERA DE TERRASSA, 121 08191 RUBI' (BARCELONA) Spain, ES |
Contact | Martin A Jordan |
Correspondent | Martin A Jordan PALEX INTL. SA CARRETERA DE TERRASSA, 121 08191 RUBI' (BARCELONA) Spain, ES |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-23 |
Decision Date | 1990-12-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EPISENSOR 75630889 2390999 Live/Registered |
KINEMETRICS, INC. 1999-01-29 |
EPISENSOR 74048826 1709269 Dead/Cancelled |
Industrias Palex, S.A. 1990-04-12 |