K-number	K071565
Device name	BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
Applicant	Molnlycke Health Care Us, LLC
Product code	KGO
Device class	Class I
Decision date	Sep 10, 2007
Decision	Substantially Equivalent
Regulation	878.4460

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View the full FDA submission: accessdata.fda.gov

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BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT

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