Premarket Notification Submission 510(k), Subpart E

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IC Title:	Premarket Notification Submission 510(k), Subpart E	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 807.90 21 CFR 807.92 21 CFR 807.93 21 CFR 807 Subpart E 21 CFR 807.87

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 8,999	Number of Respondents for Small Entity: 1,050

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	8,999	0	8,999
Annual IC Time Burden (Hours)	319,169	-39,464	358,633
Annual IC Cost Burden (Dollars)	0	0	0

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