K-number	K910783
Device name	SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
Applicant	Smith & Nephew Equipment Group
Product code	BWN
Device class	Class I
Decision date	Apr 2, 1991
Decision	Substantially Equivalent
Regulation	878.4950

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View the full FDA submission: accessdata.fda.gov

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SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M

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