K-number	K896941
Device name	AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
Applicant	American Medical Systems, Inc.
Product code	FAE
Device class	Class II
Decision date	Mar 6, 1990
Decision	Substantially Equivalent
Regulation	876.3630

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View the full FDA submission: accessdata.fda.gov

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AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS

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