Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Premarket Notification Submission 5100(k), Subpart E Modified 9470 336051 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
Other-guidance document
Other-guidance document
Total burden requested under this ICR: 9470 336051 0  
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