K-number	K972661
Device name	EYE SPHERE, CONFORMERS
Applicant	Gulden Ophthalmics
Product code	HPZ
Device class	Class II
Decision date	Oct 3, 1997
Decision	Substantially Equivalent
Regulation	886.3320

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View the full FDA submission: accessdata.fda.gov

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EYE SPHERE, CONFORMERS

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