Name: Predicase
Price: 199 USD

K-number	K983563
Device name	IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I
Applicant	Imcor
Product code	DZE
Device class	Class II
Decision date	Jan 11, 1999
Decision	Substantially Equivalent
Regulation	872.3640

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View the full FDA submission: accessdata.fda.gov

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IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I

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