K-number	K181673
Device name	Rigi10 Malleable Penile Prosthesis
Applicant	Rigicon, Inc.
Product code	FAE
Device class	Class II
Decision date	Apr 15, 2019
Decision	Substantially Equivalent
Regulation	876.3630

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Source

View the full FDA submission: accessdata.fda.gov

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Rigi10 Malleable Penile Prosthesis

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