Cleared Traditional

K821820 - MCSC6PS MEDICAL COMPONENTS (FDA 510(k) Clearance)

Jul 1982
Decision
22d
Days
Risk

K821820 is an FDA 510(k) clearance for the MCSC6PS MEDICAL COMPONENTS. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982, 22 days after receiving the submission on June 21, 1982.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K821820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1982
Decision Date July 13, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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