Name: Predicase
Price: 199 USD

K-number	K182711
Device name	Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Applicant	Kelyniam Global, Inc.
Product code	GWO
Device class	Class II
Decision date	May 21, 2019
Decision	Substantially Equivalent
Regulation	882.5320

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Source

View the full FDA submission: accessdata.fda.gov

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Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

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