Submission of 510(k) transfer documentation when more than one party lists the same 510(k)

Transfer of a Premarket Notification Clearance

Documents and Forms

Document Name Document Type
Agency Guidance.docx Other-Guidance

Information Collection (IC) Details

IC Title:	Submission of 510(k) transfer documentation when more than one party lists the same 510(k)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			Agency Guidance.docx		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,033	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	2,033	2,033
Annual IC Time Burden (Hours)	8,132	8,132
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.