The purpose of this guidance document is to identify the information that should be provided to the Food and Drug Administration (FDA) in a premarket notification (510(k)) to support a determination of substantial equivalence for intracorporeal lithotripters. Please use the document number 2235 to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance. 102 or by electronic mail at Additional CopiesĪdditional copies are available from the Internet. For questions regarding the use or interpretation of this guidance contact Donald St.Pierre at 24 ext. Comments may not be acted upon by the Agency until the document is next revised or updated. Department of Health and Human ServicesĬenter for Devices and Radiological Healthĭivision of Reproductive, Abdominal, Ear, Noseĭocument issued on: NovemPreface Public CommentĬomments and suggestions may be submitted at any time for Agency consideration to the Urology and Lithotripsy Devices Branch, HFZ-470, 9200 Corporate Blvd., Rockville Maryland, 20850.
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