Name: Predicase
Price: 199 USD

K-number	K152463
Device name	SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
Applicant	Poriferous, LLC
Product code	FWP
Device class	Class II
Decision date	Jan 20, 2016
Decision	Substantially Equivalent
Regulation	878.3550

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Source

View the full FDA submission: accessdata.fda.gov

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SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

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