Name: Predicase
Price: 199 USD

K-number	K050350
Device name	THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
Applicant	Notal Vision, Inc.
Product code	HPT
Device class	Class I
Decision date	Apr 29, 2005
Decision	Substantially Equivalent
Regulation	886.1605

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Source

View the full FDA submission: accessdata.fda.gov

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THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)

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