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METRICARE EMPTY CONTAINER SYSTEMS

K895922 Class II Traditional
Decision Date
1990-08-22
Sponsor / Applicant
Metrix Co.

Technical Specification

510(k) Submission ID K895922
Product Code LHI
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.5440
Decision Date 1990-08-22
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

METRICARE EMPTY CONTAINER SYSTEMS received FDA 510(k) clearance under submission number K895922, sponsored by Metrix Co.. 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 1990-08-22.

Classification & Regulation

This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.