K-number	K111413
Device name	BIOGEL (R) INDICATOR (R) UNDERGLOVE
Applicant	Molnlycke Health Care Us, LLC
Product code	KGO
Device class	Class I
Decision date	Jan 30, 2012
Decision	Substantially Equivalent
Regulation	878.4460

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View the full FDA submission: accessdata.fda.gov

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BIOGEL (R) INDICATOR (R) UNDERGLOVE

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