Name: Predicase
Price: 199 USD

K-number	K213538
Device name	Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Applicant	Acuity Polymers, Inc.
Product code	HQD
Device class	Class II
Decision date	Dec 30, 2021
Decision	Substantially Equivalent
Regulation	886.5916

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Source

View the full FDA submission: accessdata.fda.gov

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Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

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