Information Collection List

IC Title	Status	Responses	Hours	Dollars	Document Type	Form No.	Form Name
Premarket Notification Submission 510(k), Subpart E	Modified	9467	335782	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:		9467	335782	0
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