Qtr No. 213, New Town Yehlanka Indore 454775
Which one of the following is/are true? a. A 510(k) submission made to FDA, is applicable to Class I devices only. b. A 510(k) submission made to FDA, is applicable to Class I and Class II devices. c. Class III devices are approved by the Premarket Approval (PMA) process. d. If device is not being marketed or commercially distributed, 510(k) is not required.
All are true.
All are False
c and d are true.
b, c and d are true.
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Qtr No. 213, New Town Yehlanka Indore 454775
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