The following data is part of a premarket notification filed by Pathfinder Intl. Corp. with the FDA for Pm.
Device ID | K925980 |
510k Number | K925980 |
Device Name: | PM |
Classification | Components, Wheelchair |
Applicant | PATHFINDER INTL. CORP. 1813 N.W. 102ND WAY Gainesville, FL 32606 |
Contact | Robert J Hirko |
Correspondent | Robert J Hirko PATHFINDER INTL. CORP. 1813 N.W. 102ND WAY Gainesville, FL 32606 |
Product Code | KNN |
CFR Regulation Number | 890.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-25 |
Decision Date | 1993-03-24 |