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OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG

K050885 Traditional
Decision Date
2005-06-03
Sponsor / Applicant
Olympus Medical Systems Corporation

Technical Specification

510(k) Submission ID K050885
Product Code LFL
Medical Specialty / Panel Unknown
Decision Date 2005-06-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG received FDA 510(k) clearance under submission number K050885, sponsored by Olympus Medical Systems Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2005-06-03.

Classification & Regulation

This clearance is catalogued under FDA product code LFL , within the Unknown review panel as a device.