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Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Premarket Notification Submission 5100(k), Subpart E Modified 9474 336233 0 Form and Instruction FDA 3514 CDRH Premarket Review Submission Cover Sheet
Form and Instruction FDA 3541 Premarket Notification 510(K)
Form and Instruction FDA 3654 Standards Data Report for 510(k)s
Total burden requested under this ICR: 9474 336233 0  
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