Name: Predicase
Price: 199 USD

K-number	K970882
Device name	ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
Applicant	American Medical Devices, Inc.
Product code	MPA
Device class	Class II
Decision date	Jun 24, 1997
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)

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