K-number	K982725
Device name	OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
Applicant	Olympus America, Inc.
Product code	ITX
Device class	Class II
Decision date	Oct 23, 1998
Decision	Substantially Equivalent
Regulation	892.1570

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OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE

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