K-number	K820233
Device name	ULTRAZYME PLUS GAMMA GT(65055-65056)
Applicant	Harleco
Product code	JQB
Device class	Class I
Decision date	Feb 12, 1982
Decision	Substantially Equivalent
Regulation	862.1360

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View the full FDA submission: accessdata.fda.gov

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ULTRAZYME PLUS GAMMA GT(65055-65056)

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