Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Premarket Notification Submission 510(k), Subpart E Modified 8999 358633 0 Form and Instruction FDA 3514 CDRH Premarket Review Coversheet
Form and Instruction FDA 3541 Premarket Notification [510(K)] Status Request and Response
Form and Instruction FDA 3654 Standards Data Report for 510(k)s
Total burden requested under this ICR: 8999 358633 0  
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