K-number	K944391
Device name	OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
Applicant	Surgitek
Product code	FEN
Device class	Class II
Decision date	Feb 7, 1995
Decision	Substantially Equivalent
Regulation	876.1620

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View the full FDA submission: accessdata.fda.gov

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OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM

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