The following data is part of a premarket notification filed by Nurion Industries with the FDA for Pathfinder.
Device ID | K910601 |
510k Number | K910601 |
Device Name: | PATHFINDER |
Classification | Aid, Vision, Electronic, Battery-powered |
Applicant | NURION INDUSTRIES STATION SQUARE THREE Paoli, PA 19301 |
Contact | William P Rosen |
Correspondent | William P Rosen NURION INDUSTRIES STATION SQUARE THREE Paoli, PA 19301 |
Product Code | HPG |
CFR Regulation Number | 886.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-13 |
Decision Date | 1991-05-14 |