K-number	K803239
Device name	SOFTGOOD PRODUCTS AND SPLINTS
Applicant	Danek Medical, Inc.
Product code	IPX
Device class	Class I
Decision date	Jan 9, 1981
Decision	Substantially Equivalent
Regulation	890.3490

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View the full FDA submission: accessdata.fda.gov

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SOFTGOOD PRODUCTS AND SPLINTS

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