K-number	K971305
Device name	FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
Applicant	Gynecare Innovation Center
Product code	HIH
Device class	Class II
Decision date	Aug 11, 1997
Decision	Substantially Equivalent
Regulation	884.1690

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View the full FDA submission: accessdata.fda.gov

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FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM

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