K-number	K182757
Device name	Espire Elbow Pro, Espire Elbow Hybrid
Applicant	College Park Industries, Inc.
Product code	GXY
Device class	Class II
Decision date	Nov 29, 2018
Decision	Substantially Equivalent
Regulation	882.1320

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View the full FDA submission: accessdata.fda.gov

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Espire Elbow Pro, Espire Elbow Hybrid

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