Day

September 26, 2001
Recipient:Dentsply International, Inc Product: dental handpieces and dental accessories Date: 9/26/2001 The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation...
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IEC 62366 Usability Process and Documentation

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