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Amsco

This article was originally published in The Gray Sheet

Executive Summary

Withdraws 510(k) submission for the VHP Series 100 Rigid Endoscope Sterilizer "due to a lack of assurance of the validity of data supporting the submission," the firm announces Nov. 16. Submitted in 1992, the 510(k) was reviewed during a recent FDA inspection. Amsco plans to submit a new 510(k) for the device in 1995
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