meddevicedb.com FDA Device Reference

PHARMAFEED

K932649 Class II Traditional
Decision Date
1993-11-16
Sponsor / Applicant
Plasco, Inc.

Technical Specification

510(k) Submission ID K932649
Product Code KPE
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.5025
Decision Date 1993-11-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

PHARMAFEED received FDA 510(k) clearance under submission number K932649, sponsored by Plasco, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-11-16.

Classification & Regulation

This clearance is catalogued under FDA product code KPE and 21 CFR 880.5025, within the General Hospital review panel as a Class II device.