Name: Predicase
Price: 199 USD

K-number	K952766
Device name	RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)
Applicant	Creative Medical Designs, Inc.
Product code	HRS
Device class	Class II
Decision date	Dec 13, 1995
Decision	Substantially Equivalent for Some Indications
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)

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