meddevicedb.com FDA Device Reference

CONPHAR CRUTCH GRIPS

K803140 Class I Traditional
Decision Date
1981-01-08
Sponsor / Applicant
Conphar, Inc.

Technical Specification

510(k) Submission ID K803140
Product Code INP
Medical Specialty / Panel Physical Medicine
Regulation Citation 21 CFR 890.3790
Decision Date 1981-01-08
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CONPHAR CRUTCH GRIPS received FDA 510(k) clearance under submission number K803140, sponsored by Conphar, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1981-01-08.

Classification & Regulation

This clearance is catalogued under FDA product code INP and 21 CFR 890.3790, within the Physical Medicine review panel as a Class I device.