K-number	K921535
Device name	SUOENA AFFINITY (TM) MODEL #802
Applicant	Coloplast Corp.
Product code	KCZ
Device class	Class I
Decision date	May 11, 1992
Decision	Substantially Equivalent
Regulation	878.3800

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View the full FDA submission: accessdata.fda.gov

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SUOENA AFFINITY (TM) MODEL #802

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