K-number	K912344
Device name	MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
Applicant	Dacomed Corp.
Product code	FAE
Device class	Class II
Decision date	Oct 11, 1991
Decision	Substantially Equivalent
Regulation	876.3630

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View the full FDA submission: accessdata.fda.gov

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MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS

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