Name: Predicase
Price: 199 USD

K-number	K132161
Device name	OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
Applicant	Exactech, Inc.
Product code	JWH
Device class	Class II
Decision date	Oct 11, 2013
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS

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