K-number	K912935
Device name	AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
Applicant	American Medical Systems, Inc.
Product code	FAE
Device class	Class II
Decision date	Mar 18, 1992
Decision	Substantially Equivalent
Regulation	876.3630

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Source

View the full FDA submission: accessdata.fda.gov

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AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS

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