K-number	K912934
Device name	AMS SPHINCTER 800 URINARY PROSTHESIS
Applicant	American Medical Systems, Inc.
Product code	FAG
Device class	Class III
Decision date	Mar 18, 1992
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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AMS SPHINCTER 800 URINARY PROSTHESIS

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