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Sharn, Inc.

This article was originally published in The Gray Sheet

Executive Summary

Revises operation manual for Medisafe sonic irrigator to clarify that the product is "not designed or intended for use with endoscopes" but to clean the inside and outside "of any cannulated instrument," the company says in a May 20 letter to "The Gray Sheet". The action responds to an April 18 FDA warning letter sent to Sharn for lack of premarket clearance of the device ("The Gray Sheet" May 9, p. 31)...
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