K-number	K827712
Device name	LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES
Applicant	Cranston Medical Laboratory
Product code	—
Device class	Class unclassified
Decision date	Aug 16, 1982
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES

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