K-number	K950766
Device name	SIGMA 8000 AND SIGMA 8002
Applicant	Sigma Intl. General Medical Apparatus, Inc.
Product code	FRN
Device class	Class II
Decision date	Mar 22, 1995
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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SIGMA 8000 AND SIGMA 8002

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