K-number	K162028
Device name	PREMIUM - SHELTA Prosthetic Components
Applicant	Sweden & Martina S.P.A.
Product code	NHA
Device class	Class II
Decision date	Mar 24, 2017
Decision	Substantially Equivalent
Regulation	872.3630

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Source

View the full FDA submission: accessdata.fda.gov

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PREMIUM - SHELTA Prosthetic Components

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