K-number	K090663
Device name	AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Applicant	American Medical Systems, Inc.
Product code	FAE
Device class	Class II
Decision date	Apr 9, 2009
Decision	Substantially Equivalent
Regulation	876.3630

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Source

View the full FDA submission: accessdata.fda.gov

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AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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