K-number	K954674
Device name	P1OP2B OR P1O92T
Applicant	Kay Borch A/S
Product code	FYA
Device class	Class II
Decision date	Jan 30, 1997
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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P1OP2B OR P1O92T

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