K-number	K983259
Device name	SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
Applicant	Ab Biodisk
Product code	JWY
Device class	Class II
Decision date	Nov 25, 1998
Decision	Substantially Equivalent
Regulation	866.1640

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SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE

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