K-number	K850019
Device name	OMNI PHASE PENILE PROSTHESIS
Applicant	Dacomed Corp.
Product code	FAE
Device class	Class II
Decision date	Apr 9, 1985
Decision	Substantially Equivalent
Regulation	876.3630

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Source

View the full FDA submission: accessdata.fda.gov

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OMNI PHASE PENILE PROSTHESIS

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