K-number	K834347
Device name	FLEXI-FLATE PENILE IMPLANT
Applicant	Surgitek
Product code	FAE
Device class	Class II
Decision date	Apr 2, 1984
Decision	Substantially Equivalent
Regulation	876.3630

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View the full FDA submission: accessdata.fda.gov

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FLEXI-FLATE PENILE IMPLANT

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