K-number	K981958
Device name	LEISEGANG VIDEO COLPOSCOPE
Applicant	Netoptix Corp.
Product code	HEX
Device class	Class II
Decision date	Oct 19, 1998
Decision	Substantially Equivalent
Regulation	884.1630

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View the full FDA submission: accessdata.fda.gov

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LEISEGANG VIDEO COLPOSCOPE

Everything you need for a 510(k) submission. Nothing you don't.