Name: Predicase
Price: 199 USD

K-number	K965044
Device name	GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
Applicant	Elscint, Inc.
Product code	LNH
Device class	Class II
Decision date	Jun 16, 1997
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102

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