K-number	K980974
Device name	SAFE MINI
Applicant	Polystan A/S
Product code	DTZ
Device class	Class II
Decision date	Oct 13, 2000
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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SAFE MINI

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