Name: Predicase
Price: 199 USD

K-number	K022424
Device name	REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162
Applicant	Nobel Biocare Uas, Inc.
Product code	DZE
Device class	Class II
Decision date	Sep 27, 2002
Decision	Substantially Equivalent
Regulation	872.3640

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Source

View the full FDA submission: accessdata.fda.gov

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REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162

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