K-number	K821628
Device name	THE INFLATABLE PENILE PROSTHESIS
Applicant	American Medical Systems, Inc.
Product code	FAE
Device class	Class II
Decision date	Aug 10, 1982
Decision	Substantially Equivalent
Regulation	876.3630

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View the full FDA submission: accessdata.fda.gov

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THE INFLATABLE PENILE PROSTHESIS

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