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Home » Medispec Told to Submit 510(k) or PMA for Its Class I Device
Medispec Told to Submit 510(k) or PMA for Its Class I Device
May 21, 2010
After getting a warning letter for not getting a 510(k) or PMA for its Class I device, Medispec immediately informed the FDA that no changes had been made to the Radialspec that would require clearance or approval.