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SURGICAL LASER 510(K)s FOR "REPRESENTATIVE SAMPLE" OF PROCEDURES

This article was originally published in The Gray Sheet

Executive Summary

SURGICAL LASER 510(K)s FOR "REPRESENTATIVE SAMPLE" OF PROCEDURES are likely to be accepted by FDA, Philip Phillips, deputy director for the Office of Device Evaluation told a May 6 meeting of the General and Plastic Surgery Devices Advisory Panel in Arlington, Virginia. The panel met to discuss a recently released draft guidance on 510(k) submissions for medical lasers ("The Gray Sheet" April 25, p. 9).
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