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Form Approved: OMB No. 0910-0025 Expiration Date: May 31, 2010

FORM FDA 3645 (7/07) Guide for Preparing Annual Reports for Ultrasonic Therapy Products

Public reporting burden for this collection of information is estimated to average 26.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Food and Drug Administration CDRH (HFZ-342) 2094 Gaither Road Rockville, MD 20850 An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)

FORM FDA 3645 (7/07)