Name: Predicase
Price: 199 USD

K-number	K991324
Device name	TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
Applicant	Heinz Kurz
Product code	KHJ
Device class	Class II
Decision date	May 18, 1999
Decision	Substantially Equivalent
Regulation	874.3620

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Source

View the full FDA submission: accessdata.fda.gov

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TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)

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